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EC number: 276-696-7 | CAS number: 72490-01-8
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
- Skin irritation: not irritating, male/female, New-Zealand White rabbit, EPA 81-5, Glaza 1992
- Eye irritation: not irritating, male/female, New-Zealand White rabbit, EPA-81-4, Glaza 1992
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:
- 02 Sep 1992 to 05 Sep 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hra:(NZW)SPF strain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2694 - 3066 g
- Housing: animals were individually housed in screen-bottom stainless steel cages in temperature- and humidity-controlled quarters.
- Diet: measured amount of rabbit Diet
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 44 - 57
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: From: 02 Sep 1992 To: 05 Sep 1992 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals/sex
- Details on study design:
- TEST SITE
- Area of exposure: On day before treatment, the back and/or flanks of each animal were clipped free of hair to obtain an unblemished skin site. The test material was applied to the intact skin on each animal's back.
- Coverage: approximate exposure area of 6.25 cm2
- Type of wrap if used: 2.5 cm X 2.5 cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap and secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: using tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible irritating the skin.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- At 4, 24, 48 and 72 hours.
- Animals were weighed just before test material administration. Approximately 30 minutes after removal of the test material, the degree of erythema and oedema at each test site was read according to the Draize technique (recorded as the 4-hour score). The untreated skin of each animal was used for comparison.
SCORING SYSTEM:
- Method of calculation: method of Draize. See Table 1 in 'Any other information on materials and methods incl. tables'.
TERMINATION
- At termination the experimental phase, all animals were designated to be euthanised and discarded.
STATISTICAL ANALYSIS
- No statistical analyses were required by the protocol. - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Application of the test substance to the skin of rabbits under 4-hour semi occluded conditions resulted in no dermal irritation. The average of the 4-, 24-, 48-, and 72-hour scores is 0.0 (considered to be non-irritating).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this EPA 81-5 study, the test substance has been found not to be skin irritating to rabbits.
- Executive summary:
The objective this study was to assess the primary dermal irritation potential of the test substance in vivo, according to the EPA OPP 81-5 test guideline following GLP principles. An amount of 0.5 g unchanged test material was applied under semi-occlusive conditions for 4 hours to the clipped backs of 3 male and 3 female albino rabbits (Hra: New-Zeeland White), covering a surface area of 6.25 cm2. After 4 hours the test item was removed using tap water. Scoring was performed at 4, 24, 48 and 72 hours and after 3 days of application following the Draize system.
No signs of irritation, either erythema or oedema reactions, were observed. The 24/48/72 mean averages for these parameters were 0 for all animals.
Under the conditions of this study, the test substance was considered not to be irritating to the skin of rabbits.
Reference
Table 2: Individual irritation scores
Scores observed after |
4 hours |
24 hours |
48 hours |
72 hours |
Erythema |
0, 0, 0, 0, 0, 0 |
0, 0, 0, 0, 0, 0 |
0, 0, 0, 0, 0, 0 |
0, 0, 0, 0, 0, 0 |
Oedema |
0, 0, 0, 0, 0, 0 |
0, 0, 0, 0, 0, 0 |
0, 0, 0, 0, 0, 0 |
0, 0, 0, 0, 0, 0 |
Table 3 Mean value irritation scores
Animal |
mean 24-72 hrs |
|
erythema |
oedema |
|
1 |
0 |
0 |
2 |
0 |
0 |
3 |
0 |
0 |
4 |
0 |
0 |
5 |
0 |
0 |
6 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- 04 Sep 1992 to 07 Sep 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hra:(NZW)SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2745 – 3047 g
- Housing: individually housed in screen-bottom stainless steel cages in temperature- and humidity controlled quarters.
- Diet: a measured amount of Laboratory Rabbit Diet
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 44 ± 67
IN-LIFE DATES: From: 04 Sep 1992 To: 07 Sep 1992 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL:
- Amount applied: 0.04 g (0.01 mL weight equivalent) of the test material - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6 males / 3 females
- Details on study design:
- ANIMAL SELECTION
Six male and three female acclimated rabbits were selected and maintained during the study in the same manner as for the acclimation period. Variations from the prescribed environmental condition existed and were considered to have had no effect on the study outcome.
The animals' eyes were examined on the day before test material administration using sodium fluorescein dye procedures. Only those animals with no ocular injury or irritation were used. Animals were identified by number and corresponding ear tag. The rabbits were divided into two groups consisting of six rabbits in Group 1 and three rabbits in Group 2.
TREATMENT
Each rabbit received 0.04 g (0.1 mL weight equivalent) of the undiluted test material placed into the everted lower lid of the right eye, with the left eye serving as the untreated control. The upper and lower lids were gently held together for 1 second to prevent loss of material and then released. The eyes of the Group 1 rabbits remained unflushed following instillation of the test material. After 24 hours, the eyes were flushed with lukewarm tap water. The eyes of the Group 2 animals were flushed in the same manner for 1 minute starting 30 seconds after test material instillation.
OBSERVATIONS
Animals were weighed just before test material administration. The treated eyes of both groups were observed for ocular irritation at 1, 24, 48, and 72 hours after treatment. Irritation was graded and scored according to the Draize technique (see Table 1 in 'Any other information on materials and methods incl. tables').
TERMINATION
At termination of the experimental phase, all animals were euthanised. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 to #6
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1 to #6
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #2, #4, #5, #6
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #3
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 to #6
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance, when evaluated for its primary eye irritation potential in rabbits, produced only slight to moderate conjunctival irritation in eyes not receiving a washout until 24 hours after the treatment. In treated eyes receiving a washout approximately 30 seconds after instillation, the test material produced only slight conjunctival irritation. All treated eyes in both groups had returned to a normal appearance by 72 hours after treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this study, it was concluded that test substance was considered to be not irritating to the eyes of rabbits.
- Executive summary:
In a primary eye irritation study (EPA 81-4) performed following GLP principles, 0.1 mL of the undiluted test substance was instilled into the everted lower lid of the right eyes of nine rabbits, six with treated eyes unwashed and flushed after 24 hours, while three animals were flushed in the same manner for 1 minute starting 30 seconds after test material instillation. The left eye remained untreated and served as a control. Observations were made 1 hour, 24 hours, 48 hours and 72 hours after instillation of the test substance. Ocular irritation was evaluated by the Draize scale method.
The mean scores, calculated from the 24, 48 and 72 hour readings, for the 6 tested animals with eyes washed at 24 hours were 0 for cornea, 0 for iritis, 0.4 for conjunctiva redness, and 0 for oedema of conjunctiva. The reactions were fully reversible within the observation period. The mean scores calculated from the 24, 48 and 72 hour readings for each of the 3 tested animals with eyes washed at 30 seconds after treatment were also below the threshold values for all effects.
Under the conditions of this study, the test substance was considered to be not irritating to the eyes of rabbits.
Reference
Table 2. Individual Eye irritation Scores Group 1
Animal Number |
Sex |
Cornea |
Iris |
Conjunctivae |
Total score* |
|||
|
|
A |
B |
C |
D |
E |
F |
|
1 hour |
||||||||
1 |
male |
0 |
0 |
0 |
1 |
1 |
0 |
4.0 |
2 |
male |
0 |
0 |
0 |
1 |
1 |
1c |
6.0 |
3 |
male |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
4 |
male |
0 |
0 |
0 |
2 |
1 |
0 |
6.0 |
5 |
female |
0 |
0 |
0 |
2 |
1 |
1c |
8.0 |
6 |
female |
0 |
0 |
0 |
1 |
1 |
1c |
6.0 |
|
|
|
|
|
|
Mean |
|
5.3 |
24 hours |
||||||||
1 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
2 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
2.0 |
3 |
male |
0 |
0 |
0 |
1 |
0 |
0 |
4.0 |
4 |
male |
0 |
0 |
0 |
2 |
0 |
0 |
2.0 |
5 |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
6 |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
|
|
|
|
|
|
Mean |
|
2.0 |
48 hours |
||||||||
1 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
2 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
3 |
male |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
4 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
5 |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
6 |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
|
|
|
|
Mean |
|
0.3 |
72 hours |
||||||||
1 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
2 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
3 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
4 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
5 |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
6 |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Cornea
A - Degree of opacity
B - Area of involvement
Iris
C - Degree of iridal irritation
Conjunctivae
D - Redness
E - Chemosis
F - Discharge
* Total score = (A x B x 5) + (C x 5) + [(D + E + F) x 2].
c = Clear discharge.
Table 3. Individual Eye irritation Scores Group 2
Animal Number
|
Sex
|
Cornea
|
Iris |
Conjunctivae
|
Total score
|
|||
|
|
A |
B |
C |
D |
E |
F |
|
1 hour |
||||||||
1 t |
female |
0 |
0 |
0 |
1 |
1 |
1c |
6.0 |
2 t |
female |
0 |
0 |
0 |
1 |
1 |
1c |
6.0 |
3 t |
female |
0 |
0 |
0 |
1 |
1 |
0 |
4.0 |
|
|
|
|
|
|
mean |
|
5.3 |
24 hour |
||||||||
1 t |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
2 t |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
3 t |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
|
|
|
|
|
|
mean |
|
2.0 |
48 hours |
||||||||
1 t |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
2 t |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
3 t |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
|
|
|
|
mean |
|
0.7 |
Cornea:
A - Degree of opacity
B - Area of involvement
Iris:
C - Degree of iridal irritation
Conjunctivae:
D - Redness
E - Chemosis
F - Discharge
* Total score = (A x B x 5) + (C x 5) + [(D + E + F) x 2].
c = Clear discharge
t = No pain response after test material instillation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation in rabbits, Glaza 1992
The objective this study was to assess the primary dermal irritation potential of the test substance in vivo, according to the EPA OPP 81-5 test guideline following GLP principles. An amount of 0.5 g unchanged test material was applied under semi-occlusive conditions for 4 hours to the clipped backs of 3 male and 3 female albino rabbits (Hra: New-Zeeland White), covering a surface area of 6.25 cm2. After 4 hours the test item was removed using tap water. Scoring was performed at 4, 24, 48 and 72 hours and after 3 days of application following the Draize system.
No signs of irritation, either erythema or oedema reactions, were observed. The 24/48/72 mean averages for these parameters were 0 for all animals.
Under the conditions of this study, the test substance was considered not to be irritating to the skin of rabbits.
Eye irritation in rabbits, Glaza 1992
In a primary eye irritation study (EPA 81-4) performed following GLP principles, 0.1 mL of the undiluted test substance was instilled into the everted lower lid of the right eyes of nine rabbits, six with treated eyes unwashed and flushed after 24 hours, while three animals were flushed in the same manner for 1 minute starting 30 seconds after test material instillation. The left eye remained untreated and served as a control. Observations were made 1 hour, 24 hours, 48 hours and 72 hours after instillation of the test substance. Ocular irritation was evaluated by the Draize scale method.
The mean scores, calculated from the 24, 48 and 72 hour readings, for the 6 tested animals with eyes washed at 24 hours were 0 for cornea, 0 for iritis, 0.4 for conjunctiva redness, and 0 for oedema of conjunctiva. The reactions were fully reversible within the observation period. The mean scores calculated from the 24, 48 and 72 hour readings for each of the 3 tested animals with eyes washed at 30 seconds after treatment were also below the threshold values for all effects.
Under the conditions of this study, the test substance was considered to be not irritating to the eyes of rabbits.
Justification for classification or non-classification
Based on the available information, classification for skin and eye irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
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.