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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline under GLP. Assessment supported with ToxRTool (Schneider, K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10:189(2):138-44)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SAT 950 733 (CAS-No.: 59344-62-6)
This wrong CAS-No. of the test substance in the report R9600882 was not correct.
It should be:
89% OXM Ethanone, 1-(2-hydroxy-5-tert-nonylphenyl)-
11% tert-Nonylphenol
- Physical state: amber-coloured, vicous liquid
- Analytical purity: 89%
- Impurities (identity and concentrations): 11% Nonylphenol
- Expiration date of the lot/batch: 31.07.1996

Test animals

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre
- Weight at study initiation: 2.1-2.4 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 55 +- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 h
Observation period:
21d
Number of animals:
3
Details on study design:
The day before the experiment was started the rabbits were weighed and an area of 10 x 10 cm on the back was clipped as closely as possible with an electric clipper. On the experimental day the rabbits were physically restrained on a test table, and the clipped area was divided into four fields. The two anterior fields were used for testing the experimental preparation. To each of two 16-layer gauze patches (2.5 x 2.5 cm) 0.5 ml of the
test article was applied, and the patches were placed on the appropriate test site on the back of each rabbit. The gauze patches were secured with 2.5 cm wide adhesive tape and fixed with Micropore tape, 5 cm width, loosely wound round the trunk.
After an exposure time of 4 hours the tape and patches were removed, the test fields were marked and the treated skin was cleaned with lukewarm water. The skin reactions were read 1 hour later.
Reading was also made 24, 48 and 72 hours as weIl as 7, 14 and 21 days after termination of exposure.
The respective scores for erythema and oedema formation for the 3 readings 24, 48 and 72 hours of each rabbit were summed up separately and divided by 6. The results are the mean scores for erythema and oedema formation of the individual rabbit.
The mean scores for erythema and oedema formation in 3 rabbits used were subsequently calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.9
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.9
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritant / corrosive response data:
One hour after the end of application no erythema was seen in animal No. 833. In animal Nos. 671 and 678 a slight erythema was observed. In all rabbits a very slight oedema was seen at this time.
24 hours after removal of patches animal No. 833 showed a well-defined erythema and a slight oedema on both test sites. In animal No. 671 a moderate erythema and a moderate oedema was observed on both test sites. Animal No. 678 showed a moderate to severe erythema on
both test sites and a moderate oedema on left test area resp. a severe oedema on right test area.
The test areas of all three rabbits showed a moderate to severe erythema and a moderate oedema as weIl after 24 resp. 48 hours.
All test sites were completely covered with scales on day 7.
The test areas were easily discernible and the scales were almost completely fall off.
After 21 days the scales seemed to be removed from the test areas, in animal Nos. 671 and 833 a slight redness and an increased hair growth on the test fields were observed.
The mean individual erythema scores were 2.67, 3.00, 3.00, respectively.
The mean individual oedema scores were 2.67, 3.00, 3.17, respectively.
The mean score for the test article was 2.9 for erythema and 2.9 for oedema.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating (applying the evaluation system of the EU regulation 1272/2008).
Executive summary:

The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.The amount of 0.5 ml of the substance was applied unchanged under semi-occlusive conditions for 4 hours to the shaved skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which almost fully reversed within 21 days. Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.