Registration Dossier
Registration Dossier
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EC number: 701-365-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 to 20 March 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Federal Register 38, No 187
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Site of test substance application was abraded representing an elevated testing condition compared to intact skin.
- Principles of method if other than guideline:
- FDA Federal Register 38, No 187, Patch-Test, occusive scarified and intact skin
- GLP compliance:
- no
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.6 to 2.1 kg
- Housing: single
- Diet (ad libitum): Standard food ERKA 8300
- Water (ad libitum): tap water
- Acclimation period: NA
IN-LIFE DATES: From: 17. March To: 20. March 1980
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded areas
- Vehicle:
- physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- 2 x 500 mg moistened with 0.2 mL physiological saline solution (abraded and intact skin)
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- The flank skin was shaved at an area of 6 cm x 3 cm. One half of 3 x 3 cm was abraded by means of a scarificator. A gauze pad (2.5x2.5 cm) with 500 mg pasted test substance was applied to each 3x3 cm test area.
TEST SITE
- Area of exposure: 2 x 3 cm x 3 cm
- Type of wrap if used: polyethylene film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- shaved skin
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 hours
- Irritation parameter:
- edema score
- Remarks:
- shaved skin
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 hours
Any other information on results incl. tables
| Time after application | 24 h | 48 h | 72 h | ||||||||||||||||
| Animal number | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | |
| abraded | erythema | 2 | 2 | 4 | 2 | 1 | 2 | 2 | 1 | 3 | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 2 |
| edema | 2 | 2 | 2 | 2 | 2 | 3 | 2 | 1 | 1 | 2 | 1 | 2 | 2 | 1 | 1 | 1 | 0 | 2 | |
| shaved | erythema | 2 | 1 | 2 | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 0 | 2 | 2 | 1 | 2 | 0 | 0 | 2 |
| edema | 2 | 1 | 3 | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | |
| sum | 46 | 29 | 25 | ||||||||||||||||
| primary irritation index (24+72) | 2.96 | ||||||||||||||||||
Classification Index:
0.0 to 0.5 non irritant
0.6 to 3.0 slightly irritant
3.1 to 5.0 moderately irritant
5.1 to 8.0 severely irritant
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Slightly irritating according to Federal Register 38, No 187. No labelling according to EU guideline
- Executive summary:
Acute dermal skin irritation/corrosion study in the rabbits was carried out with a procedure similar to OECD guideline 404. 6 rabbits were treated on abraded skin with the test substance for 24 h and observation upto 72 h. The flank skin was shaved at an area of 6 cm x 3 cm. One half of 3 x 3 cm was abraded by means of a scarificator. A gauze pad (2.5x2.5 cm) with 500 mg pasted test substance was applied to each 3x3 cm test area.
Overall mean irritation score noted was 3 wherein the reactions were not fully reversible within 72 h.Primary irritation index score was 2.96.
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