Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-12-17 to 1986-01-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
2,2,4(or 2,4,4)-Trimethylhexanedioic acid of Hüls AG, purity 87 %, impurities methylpentanedoic acid and methylbutanedioic acid not quantified

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 and female
- Weight at study initiation: 2.1 - 2.6 kg
- Number of animals: 3 males, 3 females
- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K4
- Water: ad libitum, tab water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
- Examination time points: 1, 24, 48, 72 hours, 6, 8, 11, and 14 days  after patch removal; evaluation based on readings 1-4
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE 
- Preparation of test substance: warming (melting) and mixing
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml (approximately 30 °C)
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 14 days
EXAMINATION
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and  Appendix VI of 79/831/EEC

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
1.09
Max. score:
8
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: some crust in 1 male on days 6  and 8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.67
- Edema: 0.22
REVERSIBILITY: complete within 11 days; some crust in 1 male on days 6  and 8
Other effects:
no other effects

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize Scores and according to EU Directive 67/548/EEC
Conclusions:
According to the study, the test item 2,2,4(or 2,4,4)-trimethylhexanedioic acid showed slightly irritant effect on the skin of male and female rabbits.
Executive summary:

The acute skin irritation properties of 2,2,4(or 2,4,4)-trimethylhexanedioic acid were determined according to OECD Guideline 404 (1981). A dose of 0.5 ml undiluted test item per animal was applied to the shorn, intact dorsal skin of 3 male and 3 female rabbits under occlusive conditions for 4 hours. After removal of the patches the treated skin areas were rinsed with water and dried. The results were assessed 1, 24, 48 and 72 hr after patch removal. According to the study, the test item 2,2,4(or 2,4,4)-trimethylhexanedioic acid showed slightly irritant effect on the skin of male and female rabbits.