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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:
from 5 October 1992 to 4 November 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study in compliance with the GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 16 CFR 1500.41
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour exposure period, no certificate of analysis
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name in study report: AWA 1351

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.4 kg
- Fasting period before study: none
- Housing: 2/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but conditions not specified
- Humidity (%): no data
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: from 6 October 1992 to 9 October 1992

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact clipped skin and abraded clipped skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml applied to 2 sites (abraded and intact)
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 2.5 cm²
- Type of wrap if used: the treated sites were covered with gauze patches which were secured with adhesive tape. The torso was wrapped with plastic which was secured with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Daize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0.54
Max. score:
0.83
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: Overall 24 and 72h for each animal
Score:
0 - 0.5
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Mean individual score at 24 and 72h: 0.5/0.5/0.5/0.5/0.5/0.0
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
other: Overall 24 and 72h
Score:
0 - 0.5
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Mean individual score at 24 and 72h: 0.0/0.5/0.5/0.0/0.0/0.0
Irritant / corrosive response data:
Erythema, absent to well-defined at 24 hours after test article application, was absent at 72 hours.
Edema, absent to slight at 24 hours after test article application, was absent at 72 hours.
Other effects:
Diarrhoea and ano-genital soiling, noted in one animal.

Any other information on results incl. tables

Table 7.3.1/1 :Irritation scores

 

 

Rabbit No.

Mean Score

 

D4667

D4668

D4669

D4670

D4671

D4672

Erythema/Eschar

Intact 24 h

1

1

1

1

1

0

0.83

Intact 72 h

0

0

0

0

0

0

0.00

Mean (intact skin) 24-72h

0.5

0.5

0.5

0.5

0.5

0.0

0.42

Abraded 24 h

0

1

2

 1

1

0

0.83

Abraded 72 h

0

0

0

0

0

0

0.00

Oedema

Intact 24 h

0

1

1

0

0

0

0.33

Intact 72 h

0

0

0

0

0

0

0.00

Mean (intact skin) 24-72h

0.0

0.5

0.5

0.0

0.0

0.0

0.17

Abraded 24 h

0

0

1

0

0

0

0.17

Abraded 72 h

0

0

0

0

0

-

0.00

Sum of mean scores

2.16

PDII(sum of mean scores/4)

0.54

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was only slightly irritating to the skin. No classification is required according to the criteria of Regulation (EC) 1272/2008 (CLP) and of Directiev 67/548/EEC.
Executive summary:

In a GLP-compliant skin irritation study performed similarly to the OECD 404 Guideline, six maleNew Zealandwhite rabbits were dosed dermally with undilued AWA 1351. 0.5 ml of the test substance was applied to 1 intact and 1 abraded site on the clipped back for a total of 1.0 ml per rabbit. The sites were occluded for 24 hours. Those exposure conditions correspond to a worst case approach as the test guidance recommends an exposure under semi-occlusive patch and for4h. The skin reactions were evaluated by the Draize technique at 24 and 72 hours after the test item application. Body weights were recorded pre-test. The Primary irritation Index was calculated.

Erythema, absent to well-defined at 24 hours after test article application, was absent at 72 hours. Edema, absent to slight at 24 hours after test article application, was absent at 72 hours. Diarrhoea and ano-genital soiling, noted in one animal, was the only abnormal systemic sign observed during the study.

The Primary Irritation Index was 0.54.The mean individual scores calculated within 2 scoring times (24 and 72 hrs) for the unabraded skin were 0.5/0.5/0.5/0.5/0.5/0.0 for erythema and 0.0/0.5/0.5/0.0/0.0/0.0 for edema.

Under the test conditions, the test item is not classified as skin irritant when applied topically to rabbits according to the criteria of the Regulation (EC) 1272/2008 (CLP) and to the criteria of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.