Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-02-14 to 1989-02-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dodecanedioic acid of Hüls AG, purity ca. 99 %; impurities: homologous dicarboxylic acids, total 1 %

Test animals

Species:
rabbit
Strain:
other: small white russian
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.2 - 2.4 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
Concentration: 50 %
ADMINISTRATION/EXPOSURE 
- Preparation of test substance: 0.5 g ground in mortar, wetted with 0.5  ml deionized water
- Area of exposure: 6 cm2
- Occlusion: mull patch, elastic dressing - Removal of test substance: washing with warm water - Post exposure period: 6 days
Duration of treatment / exposure:
4 hour(s)
Observation period:
6 days
Number of animals:
3
Details on study design:
EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours, and 6 days after patch  removal; evaluation based on readings 1-4 - Scoring system: OECD Guideline; evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1h, 24h, 48h,72h, 6 days
Score:
0
Max. score:
0
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0
REVERSIBILITY: not applicable
Other effects:
OTHER EFFECTS: No reaction was observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Conclusions:
Classification: not irritating
Executive summary:

In a skin irritation study 0.5 g dodecanedioic acid, moistened with distilled water, was applied to the shaved skin of a group of three male rabbits for 4 hours. No skin irritation was observed.