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EC number: 203-479-6 | CAS number: 107-29-9
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- Density
- Particle size distribution (Granulometry)
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- Ecotoxicological Summary
- Aquatic toxicity
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- 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
- 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
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- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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Endpoint summary
Administrative data
Description of key information
A 50% aqueous solution of AAO was found to cause mild skin irritation effects.
A 50% aqueous solution of AAO was found to cause eye irritation.
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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP, but performed according to a US regulation.
- Qualifier:
- according to guideline
- Guideline:
- other: Draize procedure as described in 16 CFR 1500.41
- GLP compliance:
- no
- Remarks:
- Study from 1974
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: selected from healthy, acclimated animals
- Age at study initiation: adult - Preparation of test site:
- other: shaved: left half of the shaved area intact, right half of the shaved area abraded
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL or 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Type of wrap if used: square patch of surgical gauze measuring 1 inch x 1 inch
SCORING SYSTEM: Draize procedure as described in 16CFR 1500.41 - Irritant / corrosive response data:
- AAO produced
- erythema in 5 animals, in 4 on the intact and the abraded area, and in 1 only on the abraded skin.
- edema in 3 animals, in 2 on the intact and the abraded area, and in 1 only on the abraded skin. - Other effects:
- 1 animal died.
- Conclusions:
- The test material, 50% AAO, is a mild irritant to intact skin.
Reference
Findings | Exposure time (h) | Exposure unit (value) | |||||
Rabbit 1 | Rabbit 2 | Rabbit 3 | Rabbit 4 | Rabbit 5 | Rabbit 6 | ||
Erythema and eschar formation | |||||||
intact skin | 24 | 1 | 1 | 0 | + | 1 | 1 |
intact skin | 72 | 0 | 0 | 0 | + | 0 | 0 |
abraded skin | 24 | 1 | 4 | 1 | + | 1 | 1 |
abraded skin | 72 | 2 | 4 | 0 | + | 0 | 0 |
Edema formation | |||||||
intact skin | 24 | 0 | 0 | 0 | + | 1 | 1 |
intact skin | 72 | 0 | 0 | 0 | + | 0 | 0 |
abraded skin | 24 | 0 | 1 | 0 | + | 1 | 1 |
abraded skin | 72 | 0 | 0 | 0 | + | 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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study and not according to a recent international test guideline but according to a US regulation. The results are well documented.
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- GLP compliance:
- no
- Remarks:
- Study from 1974
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Young adult albino rabbits, selected from healthy, acclimated animals - Controls:
- no
- Observation period (in vivo):
- 72 h - Ocular reactions were observed and recorded at 24, 48 and 72 h after instillation of the test material.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- No washout
SCORING SYSTEM: very similar to DRAIZE - Irritant / corrosive response data:
- The test material produced corneal effects in 5 of the animals, iridial effects in 3 of the animals and conjunctival effects in all 6. None of these effects cleared by the 72 h observation period.
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
- Conclusions:
- On the basis of the data the test material is a severe irritant to the eye.
- Executive summary:
The test material produced corneal effects in 5 of the animals, iridial effects in 3 of the animals and conjunctival effects in all 6. None of these effects cleared by the 72 h observation period.
Rabbits were not observed after 21 days, so it cannot be concluded if the observed effects are reversible or not.
Reference
Rabbit |
|
Tissue |
24 h |
48 h |
72 h |
1 |
A |
Cornea opacity |
1 |
1 |
1 |
|
B |
Cornea Area |
4 |
4 |
4 |
|
|
(1) Cornea Total = (AxB) x 5 |
20 |
20 |
20 |
|
C |
Iris |
2 |
1 |
1 |
|
|
(2) Iris Total = (C) x 5 |
10 |
5 |
5 |
|
D |
Conjunctiva Redness |
1 |
2 |
2 |
|
E |
Conjunctiva Chemosis |
3 |
3 |
2 |
|
F |
Conjunctiva discharge |
3 |
3 |
3 |
|
|
(3) Conjunctiva Total = (D+E+F) x 2 |
14 |
16 |
14 |
|
|
Totals Added = (1+2+3) |
44 |
41 |
39 |
|
|
|
|
|
|
2 |
A |
Cornea opacity |
1 |
1 |
1 |
|
B |
Cornea Area |
4 |
4 |
4 |
|
|
(1) Cornea Total = (AxB) x 5 |
20 |
20 |
20 |
|
C |
Iris |
0 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
2 |
2 |
|
E |
Conjunctiva Chemosis |
2 |
2 |
1 |
|
F |
Conjunctiva discharge |
3 |
3 |
3 |
|
|
(3) Conjunctiva Total = (D+E+F) x 2 |
12 |
14 |
12 |
|
|
Totals Added = (1+2+3) |
32 |
34 |
32 |
|
|
|
|
|
|
3 |
A |
Cornea opacity |
1 |
1 |
1 |
|
B |
Cornea Area |
4 |
2 |
2 |
|
|
(1) Cornea Total = (AxB) x 5 |
20 |
10 |
10 |
|
C |
Iris |
1 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
5 |
0 |
0 |
|
D |
Conjunctiva Redness |
2 |
2 |
2 |
|
E |
Conjunctiva Chemosis |
3 |
2 |
2 |
|
F |
Conjunctiva discharge |
3 |
2 |
2 |
|
|
(3) Conjunctiva Total = (D+E+F) x 2 |
16 |
12 |
12 |
|
|
Totals Added = (1+2+3) |
41 |
22 |
22 |
|
|
|
|
|
|
4 |
A |
Cornea opacity |
1 |
1 |
1 |
|
B |
Cornea Area |
4 |
4 |
4 |
|
|
(1) Cornea Total = (AxB) x 5 |
20 |
20 |
20 |
|
C |
Iris |
0 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
1 |
3 |
2 |
|
E |
Conjunctiva Chemosis |
3 |
4 |
3 |
|
F |
Conjunctiva discharge |
3 |
3 |
3 |
|
|
(3) Conjunctiva Total = (D+E+F) x 2 |
14 |
20 |
16 |
|
|
Totals Added = (1+2+3) |
34 |
40 |
36 |
|
|
|
|
|
|
5 |
A |
Cornea opacity |
2 |
2 |
1 |
|
B |
Cornea Area |
4 |
4 |
4 |
|
|
(1) Cornea Total = (AxB) x 5 |
40 |
40 |
20 |
|
C |
Iris |
2 |
1 |
0 |
|
|
(2) Iris Total = (C) x 5 |
10 |
5 |
0 |
|
D |
Conjunctiva Redness |
2 |
2 |
1 |
|
E |
Conjunctiva Chemosis |
2 |
2 |
1 |
|
F |
Conjunctiva discharge |
3 |
2 |
2 |
|
|
(3) Conjunctiva Total = (D+E+F) x 2 |
14 |
12 |
8 |
|
|
Totals Added = (1+2+3) |
64 |
57 |
28 |
|
|
|
|
|
|
6 |
A |
Cornea opacity |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
|
|
(1) Cornea Total = (AxB) x 5 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
|
|
(2) Iris Total = (C) x 5 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
2 |
2 |
2 |
|
E |
Conjunctiva Chemosis |
2 |
2 |
1 |
|
F |
Conjunctiva discharge |
3 |
2 |
1 |
|
|
(3) Conjunctiva Total = (D+E+F) x 2 |
14 |
12 |
8 |
|
|
Totals Added = (1+2+3) |
14 |
12 |
8 |
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
There is one skin irritation study available (Morgareidge and Bailey 1974 (K2)). The test was conducted on 6 albino rabbits. The test material, 50% AAO in water, was applied on intact skin and on abraded skin. The test material was introduced under a patch of surgical gauze and the patches were removed after 24 h.
Application of the test material on the intact skin did not result in a score >1 (according to Draize) after 24 and 72 h for any of the observed effects. Applied on the abraded skin, the effects were a bit more pronounced. Overall, the study report concluded that 50% AAO is a mild irritant to the rabbit skin. When compared to the CLP criteria, classification as a skin irritant is not deemed required.
Eye irritation
One eye irritation study is available (Bailey and Morgareidge 1974 (K2)). The test was conducted on 6 young adult albino rabbits. The test material, 50% AAO in water, produced corneal effects in 5 rabbits, iridial effects in 3 rabbits and conjunctival effects in all six. None of these effects cleared by the 72 h observation period.
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Skin irritation/corrosion
Based on the results of the available study report, AAO is not classified as a skin irritant. The test substance does not meet the criteria described in Table 3.2.2 (CLP Annex I) as only 1 of 6 animals showed pronounced signs of skin irritation upon administration of 50% AAO on abraded skin.
Eye irritation
In 5 out of 6 rabbits, a corneal opacity of ≥ 1 (calculated as the mean score following grading at 24, 48 and 72 h after installation of the test material) is observed. According to CLP (Annex I, Table 3.3.2), this results in a classification as Eye irritant Category 2.
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