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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:
04 - 18 Feb 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no experimental 48 h reading performed, only 72 h observation period, 24 h occlusive application, analytical purity of test substance not specified, limited documentation available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive dressing, 24 instead of 4 h exposure, no experimental 48 h reading performed, limited documentation, analytical purity of test substance not specified
Qualifier:
according to
Guideline:
other: FHSA
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): butyl stearate, octadecanoic acid, butyl ester
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours
Observation period:
72 hours (as all signs of irritation were fully reversible)
Reading time points: 24 and 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back skin, 2.5 cm x 2.5 cm
- Type of wrap if used: clear plastic trunk bands

SCORING SYSTEM: according to Draize

The animals were immobilized during the 24 hour exposure period.
Upon removal of the patches the resulting reactions were evaluated on the basis weighted scores. Evaluations were again made after 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Other effects:
The skin scores upon treatment of abraded skin were similar to intact skin.

Any other information on results incl. tables

Table 1: Results of skin irritation study

Observation time

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

24 h

0

0

1

0

0

0

0

0

0

0

1

0

48 h

No experimental data available; for calculation of mean scores, the 48 h values were assumed to bet he same as those at 24 h (worst case assumption)

72 h

0

0

0

0

0

0

0

0

0

0

0

0

 

Table 2: Calculation of mean scores

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value 24 + 48 + 72 h

0.00

0.00

0.67

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.67

0.00

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h). 

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
CLP: not classified