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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12. Feb. 2003 - 26. Feb. 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification : BENZOlC ACID ISONONYLESTER
Description : colourless liquid
Batch number : 1276/00576
Date received : 06 January 2003
Storage conditions : room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
At the start of the study the animals were in the weight range of 2.0 to 3.5 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label. The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) supplied by International Product Supplies Limited, Wellingborough, Northants, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity ofthe study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18 :00) and twelve hours darkness.
The animals were provided with environmental emichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
Duration of treatment / exposure:
4 h
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: up to 7 days post application
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
> 1
Max. score:
2
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 1
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
>= 1
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 1
Max. score:
1
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
Very slight to well-defined erythema was noted at all treated skin sites at the 1 and 24-hour observations with very slight erythema at the 48 and 72-hour observations. Very slight oedema was noted at all treated skin sites at the 1 and 24-hour observations and at two
treated skin sites at the 48 and 72-hour observations. Moderate desquamation was noted at all treated skin sites at the 7-day observation.
All treated skin sites appeared normal at the 14-day observation.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 2,0 and was classified as a MILD IRRlTANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to the
EU labelling regulations Commission Directive 2001/591EC.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit according to OECD 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002) and Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation).

A single 4-hour, semi-occluded application ofthe test material to the intact skin ofthree rabbits produced very slight to well-defined erythema and very slight oedema. Moderate desquamation was also noted. All treated skin sites appeared normal at the 14-day observation.

The test material produced a primary irritation index of 2.0 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC.