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EC number: 267-051-0 | CAS number: 67774-74-7
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- 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
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- Toxicological Summary
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- Irritation / corrosion
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
A skin irritation study in rabbits was performed according to EEC Directives 83/462 and 84/449. A mild irritating effect on the skin was observed with effects not fully resolving after 7 days.
An eye irritation study in rabbits was carried out as per EEC Directives 83/462 and 84/449. No irritating effects on the eye throughout the whole study was observed (7 days).
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:
- 15 Jun 1992 to 22 Jun 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directives 83/467 and 84/449
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: stainless steel cages
- Diet: pellet complete diet
- Water: Purified water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 15 Jun 1992 To 22 Jun 1992 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0, 24, 48, and 72 hours, and 5 and 7 days after removal of the patches.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm gauze pads secured by thin bands of adhesive wrap, then covered with rubberized cloth.
SCORING SYSTEM
- Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0.62
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.667
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: #5, #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: #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:
- Erythema (maximum score of 4) was seen in all animals at the 24 hour observation. In 3 of the animals, the erythema persisted throughout the experiment, and was not fully resolved by the end of the experiment on day 7. Oedema was seen in one animal at the 24 hour observation only.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance caused only mild irritation, however, symptoms were not fully resolved by the end of the experiment.
- Executive summary:
This study examined the potential of the test substance to cause skin irritation. Six rabbits were exposed to undiluted test substance on shaved skin for 4 hours. After the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 hours after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after end of exposure. At the 24 hour observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of oedema (score of 1). There were no signs of oedema in any animal at the 48 hour observation. Erythema persisted in all animals through day 5, and in 3 of the animals, erythema was not fully resolved at the end of the experiment on day 7. Though all symptoms of irritation were mild, the irritation was not fully reversible within the study period.
Reference
Table 1: Results of Skin Irritation Study
Time after patch removal |
Animal |
||||||
Erythema |
1 |
2 |
3 |
4 |
5 |
6 |
Mean |
1 hr |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
24 hrs |
2 |
1 |
2 |
1 |
1 |
1 |
1.33 |
48 hrs |
2 |
1 |
1 |
1 |
1 |
1 |
1.17 |
72 hrs |
1 |
1 |
1 |
1 |
1 |
1 |
1.00 |
5 days |
1 |
1 |
1 |
1 |
1 |
1 |
1.00 |
7 days |
0 |
0 |
1 |
0 |
1 |
1 |
0.50 |
Oedema |
|||||||
1 hr |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
24 hrs |
1 |
0 |
0 |
0 |
0 |
0 |
0.17 |
48 hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
72 hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
5 days |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
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:
- 15 Jun 1992 to 22 Jun 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directives 83/467 and 84/449
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: stainless steel cages
- Diet: pellet complete diet
- Water: filtered tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 15 Jun 1992 to 22 Jun 1992 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100% - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 1, 24, 48, and 72 hours, and 7 days after start of exposure
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM:
- Draize
- Irritation parameter:
- overall irritation score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity 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:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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:
- No signs of irritation or corrosion were seen in any animal during any of the observations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not an eye irritant.
- Executive summary:
This study examined the potential of the test substance to cause eye irritation. 0.1 mL of test substance was placed in one eye of 6 rabbits. The untreated eyes served as controls. The eyes were examined at 1, 24, 48, and 72 hours, and 7 days after start of exposure for signs of irritation. No signs of irritation were seen in any animal at any observation. The test substance is considered no irritating to eyes.
Reference
Table 1: Results of Eye Irritation Study - Mean Scores
Observation |
Cornea |
Iris |
Conjunctiva (Redness) |
Conjunctiva (Chemosis) |
1 hr |
0 |
0 |
0 |
0 |
24 hrs |
0 |
0 |
0 |
0 |
48 hrs |
0 |
0 |
0 |
0 |
72 hrs |
0 |
0 |
0 |
0 |
7 days |
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
Skin irritation study:
This study examined the potential of the test substance to cause skin irritation. 6 rabbits were exposed to undiluted test substance on shave skin for 4 hours. After the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 hours after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after end of exposure. At the 24 hor observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of oedema (score of 1). There were no signs of oedema in any animal at the 48 hour observation. Erythema persisted in all animals through day 5, and in 3 of the animals, erythema was not fully resolved at the end of the experiment on day 7. Though all symptoms of irritation were mild, the irritation was not fully reversible within the study period.
Eye irritation study
This study examined the potential of the test substance to cause eye irritation. 0.1 mL of test substance was placed in one eye of 6 rabbits. The untreated eyes served as controls. The eyes were examined at 1, 24, 48, and 72 hours, and 7 days after start of exposure for signs of irritation. No signs of irritation were seen in any animal at any observation. The test substance is considered not irritating to eyes.
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.
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