Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 448-300-4 | CAS number: 88642-03-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Based on the results of an OECD 404 compliant study, the test item was found to be irritating to rabbit skin.
Based on the results of an OECD 405 compliant study, the test item was found to be not irritating the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-11-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The in vivo study on skin irritation with the registration substance was completed in 2003. Therefore, in compliance with Regulation (EC) 1907/2006 (REACH) performing an additional in vitro skin irritation study is considered scientifically not necessary.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Chbb:HM(SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 18 - 22 months
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: individually in PPO cages (floor area: 2576 sq. cm) with perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: approx. one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 55 +/- 15 %
- Air changes: 10 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: olive oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: ca. 0.1 mL for a better contact to the skin - Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 d
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap: 16-layer gauze patch (2.5 cm x 2.5 cm) was secured semi-occlusively with adhesive Gothaplast tape (2.5 cm wide) and fixed with Gothaplast tape (5 cm wide) loosely wound round the trunk
REMOVAL OF TEST SUBSTANCE
- Washing: with mild soap and lukewarm water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
The skin reactions were read immediately and 1 h, 24 h, 48 h as well as 72 h after the termination of exposure as well as on day 7, 14 and 21
SCORING SYSTEM:
According to guideline and Draize scoring system:
Erythema and Eschar Formation Score
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Oedema Formation Score
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritant / corrosive response data:
- 7 days after the termination of exposure isolated scales were observed an the anterior left test field of animal No. 2425 as well as slight crusty scales an the middle and posterior left test field. Animals No. 2461 and No. 2462 showed flat, yellow scales an the whole anterior right test field.
14 days after the termination of exposure isolated, small scales were still recorded an the middle and posterior left test field of animal No. 2425. Animals No. 2461 and No. 2462 still showed isolated scales an the anterior right test fields.
21 days after the termination of exposure animals No. 2425, No. 2461 and No. 2462 were free of any signs of skin irritation. - Other effects:
- - Other adverse local effects:
none
- Other adverse systemic effects: not observed - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the results of this study, the test item was found to be irritating to rabbit skin.
- Executive summary:
The skin irritant effect of the test item was investigated according to the method recommended in the OECD Guideline No. 404, "Acute Dermal Irritation/ Corrosion", 2002, and OECD document "Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures", 2001, modified. Based on a weight-of-the-evidence analysis of all existing relevant information carried out on the sponsor's own authority the in vivo testing of the test item was considered to be justified. During an initial test using one female albino rabbit a sequential application (exposure time 3 min, 1 h and 4 h) of the test item was carried out on one site of the left back area each. The skin was examined for signs of irritation straight after as well as 1 h, 24 h, 48 h and 72 h after the termination of exposure as well as on day 7, 14 and 21. Since the animal did show very well defined signs of skin Irritation but no full thickness destruction of the skin within the observation period of 21 days it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on the classification criteria (CLP). Two female albino rabbits were exposed to the test item at one skin site on the back during the confirmatory test. After 4-hour exposure time the test item was removed and the skin was examined 1 h, 24 h, 48 h and 72 h after the termination of exposure as well as on day 7, 14 and 21. Skin reactions ranging from well defined to severe were observed in these animals, too. The observation period was extended to the complete reversibility of all effects on day 21 according to the sponsor's request. Under the experimental conditions described in this report the mean scores after the 4-hour exposure were:
Animal No
Erythema
Oedema
2425
3.00
2.00
2461
3.67
3.00
2462
4.00
3.33
Under the experimental conditions of this study, the mean score for erythema was 3.6 and for oedema 2.8. Based on the results of this study the test item is considered to be irritating to rabbit skin.
Reference
Table 1
Animal No |
Exposure |
Test field |
Ersthema formation observed after x hours after termination
|
Mean (24 -72 h) |
Oedema formation after x hours after termination |
Mean (24 -72 h) |
||||||||
|
|
|
0 |
1 |
24 |
48 |
72 |
0 |
1 |
24 |
48 |
72 |
||
2425 |
3 min |
Anterior le. |
0 |
1 |
2 |
2 |
2 |
|
0 |
0 |
0 |
0 |
0 |
|
1 h |
Median le. |
0 |
1 |
3 |
3 |
3 |
|
0 |
0 |
2 |
2 |
2 |
|
|
4 h |
Posterior le. |
1 |
2 |
3 |
3 |
3 |
3.00 |
0 |
0 |
2 |
2 |
2 |
2.00 |
|
2461 |
4 h |
Anterior le. |
|
2 |
3 |
4 |
4 |
3.67 |
|
2 |
3 |
3 |
3 |
3.00 |
2462 |
4h |
Anterior le. |
|
2 |
4 |
4 |
4 |
4.00 |
|
1 |
4 |
3 |
3 |
3.33 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-12-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The in vivo study on eye irritation/corrosion with the registration substance was completed in 2004. Therefore, in compliance with Regulation (EC) 1907/2006 (REACH) performing an additional in vitro eye irritation/corrosion study is considered scientifically not necessary.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 4.5 months
- Weight at study initiation: 2.1 - 2.2 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 d
ENVIRONMENTAL CONDITIONS
- Temperature: 20+/- 3 °C
- Humidity: 30 - 70 %
- Air changes: not specified
- Photoperiod: 12/12 hrs dark / hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 6 days
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not done
SCORING SYSTEM: according to the guideline:
CORNEA (Opacity: degree of density (area most dense taken for reading))
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 nacreous areas, no details of Iris visible, size of pupil barely discernible
4 opaque cornea, iris not discernible through the opacity
IRIS
0 normal
1 markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection; iris reactive to light (a sluggish reaction is considered to be an effect)
2 haemorrhage, gross destruction, or no reaction to light
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
0 blood vessels normal
1 some blood vessels hyperaemic (injected)
2 diffuse, crimson colour, individual vessels not easily discernible
3 diffuse beefy red
Chemosis: Swelling (refers to lids and/or nictitating membranes)
0 normal
1 some swelling above normal
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test item was irritating the eye.
- Executive summary:
A study according to OECD 405 was conducted with the test item. A single instillation of 0.1 mL per animal into the conjuncitval sac of the right eye of three rabbits caused the follwoing changes:
Corneal opacity was observed in all animals:
animal nos. 1 and 2: 24 hours (grade 1) after instillation;
animal no. 3: 24 hours (grade 2) and 48 hours (grade 1) after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal nos. 1 and 2 (1/4 of the surface) and animal no. 3 (1/2 of the surface).
Irritation of the iris (grade 1) was observed in all animals 24 hours, in animal no. 3 until 48 hours after instillation.
Conjunctival redness (grade 1 or 2) was observed in all animals 60 minutes to 48 hours, in animal nos. 2 and 3 until 5 days after instillation.
Conjunctival chemosis (grade 1 or 2) was observed in all animals 60 minutes to 24 hours, in animal nos. 2 and 3 until 5 days after instillation.
There were no systemic intolerance reactions.
Based on the results, the test item is considered to be not irritating to the eye.
Reference
Table 1 - Eye irritation scores of the right eye of treated animals (animal number 1 / 2 / 3)
Time after administration |
Cornea (opacity) |
Iris |
Conjunctiva (redness) |
chemosis |
Before dosing |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
1 h |
0/0/0 |
0/0/0 |
2/2/2 |
1/1/1 |
24 h |
1/1/2 |
1/1/1 |
2/2/2 |
1/2/1 |
48 h |
0/0/1 |
0/0/1 |
1/2/2 |
0/2/1 |
72 h |
0/0/0 |
0/0/0 |
0/1/1 |
0/1/1 |
4 d |
-/0/0 |
-/0/0 |
-/1/1 |
-/1/1 |
5 d |
-/0/0 |
-/0/0 |
-/1/1 |
-/1/1 |
6 d |
-/0/0 |
-/0/0 |
-/0/0 |
-/0/0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An in vitro skin irritation and eye irritation/corrosion study were not conducted because adequate data from in vivo testing are available.
Skin irritation in vivo, OECD 404
The skin irritant effect of the test item was investigated according to the method recommended in the OECD Guideline No. 404, "Acute Dermal Irritation/ Corrosion", 2002, and OECD document "Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures", 2001, modified. Based on a weight-of-the-evidence analysis of all existing relevant information carried out on the sponsor's own authority the in vivo testing of the test item was considered to be justified. During an initial test using one female albino rabbit a sequential application (exposure time 3 min, 1 h and 4 h) of the test item was carried out on one site of the left back area each. The skin was examined for signs of irritation straight after as well as 1 h, 24 h, 48 h and 72 h after the termination of exposure as well as on day 7, 14 and 21. Since the animal did show very well defined signs of skin Irritation but no full thickness destruction of the skin within the observation period of 21 days it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on the classification criteria (CLP). Two female albino rabbits were exposed to the test item at one skin site on the back during the confirmatory test. After 4-hour exposure time the test item was removed and the skin was examined 1 h, 24 h, 48 h and 72 h after the termination of exposure as well as on day 7, 14 and 21. Skin reactions ranging from well defined to severe were observed in these animals, too. The observation period was extended to the complete reversibility of all effects on day 21 according to the sponsor's request. Under the experimental conditions described in this report the mean scores after the 4-hour exposure were:
Animal No |
Erythema |
Oedema |
1 |
3.00 |
2.00 |
2 |
3.67 |
3.00 |
3 |
4.00 |
3.33 |
Under the experimental conditions of this study, the mean score for erythema was 3.6 and for oedema 2.8. Based on the results of this study the test item is considered to be irritating to rabbit skin.
Eye irritation, in vivo, OECD 405
A study according to OECD 405 was conducted with the test item. A single instillation of 0.1 mL per animal into the conjuncitval sac of the right eye of three rabbits caused the follwoing changes:
Corneal opacity was observed in all animals:
animal nos. 1 and 2: 24 hours (grade 1) after instillation; animal no. 3: 24 hours (grade 2) and 48 hours (grade 1) after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal nos. 1 and 2 (1/4 of the surface) and animal no. 3 (1/2 of the surface).
Irritation of the iris (grade 1) was observed in all animals 24 hours, in animal no. 3 until 48 hours after instillation.
Conjunctival redness (grade 1 or 2) was observed in all animals 60 minutes to 48 hours, in animal nos. 2 and 3 until 5 days after instillation.
Conjunctival chemosis (grade 1 or 2) was observed in all animals 60 minutes to 24 hours, in animal nos. 2 and 3 until 5 days after instillation.
There were no systemic intolerance reactions.
Based on the results, the test item is considered to be not irritating to the eye.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data, the test item is classified and labelled as irritating
to the skin Cat. 2 (H315: "Causes skin irritation") according to
Regulation (EC) No 1272/2008 (CLP), as
amended for the fourteenth time in Regulation (EU) 2020/217. The
test item does not require classification as irritating to the eye
according to CLP.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.