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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyloctanoic acid
EC Number:
248-570-1
EC Name:
2-butyloctanoic acid
Cas Number:
27610-92-0
Molecular formula:
C12H24O2
IUPAC Name:
2-butyloctanoic acid
Test material form:
liquid
Details on test material:
- Name of test material: 2-butyl octanoic acid
- Molecular formula: C12H24O2
- Molecular weight: 200.32 g/mole
- Smiles notation: O=C(O)C(CCCCCC)CCCC

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Strain: New Zealand White
- Sex: female
- Source: Charles River Italia S. p. A. (Como), Italy (supplier), P. O. A. D. A., Mandello Lario (Como),Italy (breeder)
- Age: 9 – 11 weeks
- Weight at study initiation: 1.8 – 2.3 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent area of untreated skin
Amount / concentration applied:
- Total volume applied: 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test article was applied undiluted.
- Area of exposure: The test substance was applied to a gauze patch (2.5 cm x 2.5 cm). The patch was placed on the appropriate test field. A strip of aluminium foil was placed over the treated site and the whole trunk was wrapped with an elastic adhesive bandage.
- Occlusion: semi-occlusion
- Vehicle: none
- Total volume applied: 0.5 ml
- Postexposure period: 14 days
- Removal of test substance: After 4 hours exposure the bandage and patch were taken off and the test substance was removed by gentle swapping of the skin with cotton wool soaked in water at approximate body temperature.
EXAMINATIONS
- Scoring system: according to OECD 404
- Examination time points: Skin reactions were read immediately and 1, 24, 48 and 72 hours as well as 7 and 14 days after the end of the exposure period

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks:
Desquamation after 7 d, reversible after 14 d
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks:
Desquamation reversible after 14 d
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks:
Desquamation reversible after 14 days
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
other: desquamation
Basis:
other: all animals
Time point:
other: day 7
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
No irritation was observed in any animal approximately 1 hour following the 4 hour period of exposure. Very slight erythema (score of 1) was observed in all animals at the subsequent 24 and 48 hour examinations, remaining in 2 animals at the 72 hour examination. Desquamation was noted in all 3 animals after 7 days. Recovery had occurred within 14 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item.
Executive summary:

The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item.