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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
other: Study performed according to internationally accepted testing guideline, well documented.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approx. 12-16 weeks
- Weight at study initiation: 2.40 - 2.52 kg
- Housing: single housing in suspended metal cages
- Diet (e.g. ad libitum): free access to Rabbit Diet, supplied by Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (e.g. ad libitum): free access to mains drinking water throughout the study
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13 - 22
- Humidity (%): 55 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Arachis oil B.P.
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): For the purpose of this study the test material was freshly prepared at a concentration of 20% w/w in arachis oil. The test material preparation was warmed to aid solubilisation.
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
2 females, 1 male
Details on study design:
TEST SITE
- Area of exposure: clipped skin on the dorsal/flank area, intact epidemis
- % coverage: not mentioned
- Type of wrap if used: On the application area a gauze patch (2.5 cm x 2.5 cm) was placed. The patch was secured in position by a strip of surgical adhesive tape (BLENDERM: approx. size 2.5 cm x 4.0 cm). The trunk of the animals was wrapped in an elasticated corset (TUGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool soaked in diethyl ether
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize J. H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.56
- Edema: 0
Other effects:
Desquamation was commonly noted during the study.

Table 1: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 2

Max. score: 1

60 min

1/1/1

 0/0/0

24 h

1/0/1

 0/0/0

48 h

 1D/0D/1

 0/0/0

72 h

 0D/0D/1D

 0/0/0

Average 24h, 48h, 72h

0.56

 0

Reversibility*)

 c.

 c.

Average time (unit) for reversion

 7 days

 not relevant

 

*) Reversibility: c. = completely reversible; D = desquamation

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test material, octanoic acid, monoester with glycerol (20% in arachis oil S.P.), was found to be a mild irritant to rabbit skin. No corrosive effects were noted.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Study performed according to internationally accepted testing guideline, well documented.

Justification for selection of eye irritation endpoint:
Study performed according to internationally accepted testing guideline, well documented.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

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