Registration Dossier
Registration Dossier
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EC number: 943-670-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- June 1st, 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959, of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone
- EC Number:
- 943-670-8
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 1.5 to 2 kg- Housing: individual housing in metal cages- Diet: NAFAG, Gossau SG, standard rabbit food, ad libitum- Water: ad libitum- Acclimation period: 4 days minimumENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1- Humidity (%): 55 ± 5- Photoperiod (hrs dark / hrs light): 10 hours light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and non-abraded skin
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 ml
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 0 h, 48 h after patch removal
- Number of animals:
- 6 animals: 3 male and 3 female
- Details on study design:
- TEST SITE- Area of exposure: 2.5 cm × 2.5 cm
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #6
- Time point:
- other: 24, 48 and 72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- other: no dermal effects observed
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #3, #4, #5
- Time point:
- other: mean 24, 48 and 72h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- other: 24, 48 and 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no dermal effects observed
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no dermal effects observed
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #3, #5
- Time point:
- other: mean 24, 48 and 72h
- Score:
- ca. 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #6
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48 and 72h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: abraded skin
Any other information on results incl. tables
Results
Intact skin
| Animal/sex | Reaction | 0 h | 24 h | 48 h | 72 h | Mean 24, 48 and 72 h |
| 1 M | Erythema | 0 | 0 | 0 | 0 | 0 |
| 2 M | Erythema | 0 | 0 | 0 | 0 | 0 |
| 3 M | Erythema | 0 | 0 | 0 | 0 | 0 |
| 4 F | Erythema | 0 | 0 | 0 | 0 | 0 |
| 5 F | Erythema | 0 | 0 | 0 | 0 | 0 |
| 6 F | Erythema | 0 | 0 | 0 | 0 | 0 |
| 1 M | Oedema | 1 | 1 | 0 | 0 | 0,33 |
| 2 M | Oedema | 0 | 0 | 0 | 0 | 0 |
| 3 M | Oedema | 0 | 0 | 0 | 0 | 0 |
| 4 F | Oedema | 0 | 0 | 0 | 0 | 0 |
| 5 F | Oedema | 0 | 0 | 0 | 0 | 0 |
| 6 F | Oedema | 1 | 1 | 0 | 0 | 0,33 |
Scarified skin
| Animal/sex | Reaction | 0 h | 24 h | 48 h | 72 h | Mean 24, 48 and 72 h |
| 1 M | Erythema | 0 | 0 | 0 | 0 | 0 |
| 2 M | Erythema | 0 | 0 | 0 | 0 | 0 |
| 3 M | Erythema | 0 | 0 | 0 | 0 | 0 |
| 4 F | Erythema | 0 | 0 | 0 | 0 | 0 |
| 5 F | Erythema | 0 | 0 | 0 | 0 | 0 |
| 6 F | Erythema | 0 | 0 | 0 | 0 | 0 |
| 1 M | Oedema | 2 | 2 | 0 | 0 | 0.67 |
| 2 M | Oedema | 1 | 1 | 0 | 0 | 0.33 |
| 3 M | Oedema | 2 | 2 | 0 | 0 | 0.67 |
| 4 F | Oedema | 3 | 3 | 0 | 0 | 1 |
| 5 F | Oedema | 2 | 2 | 0 | 0 | 0.67 |
| 6 F | Oedema | 1 | 1 | 0 | 0 | 0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Non-skin irritant
- Executive summary:
The substance was tested for skin irritation potential using the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959, the US Association of Food and Drug Officials (AFDO).
2.5 cm × 2.5 cm intact and abraded skin of 3 male and 3 female Himalayan rabbits were exposed to 0.5 ml of test substance in an occlusive preparation for 24 h. Skin reactions were recorded at 0 h and 48 h after patch removal. For the purpose of calculating erythema and edema scores at 24, 48 and 72 h after patch removal, the following method was adopted: scores at 0 h were taken as scores at 24 h and scores at 48 h were also taken as scores at 72 h.
Intact skin showed no skin reactions at all for erythema; 2/6 rabbits show very slight edema at 0h, but this skin reactions were reversible within 48h.
No erythema was observed also in scarified skin. Slight edema was observed in scarified skin at 0 h. These skin reactions were reversible within 48 h.
For all animals, the calculation of mean skin reaction scores (24, 48 and 72 h) after patch removal gave the following values for intact skin: erythema score = 0 and oedema score = 0.1; and for abraded skin: erythema score = 0 and oedema score < 1.
Therefore, the test substance is a non-skin irritant.
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