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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:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with OECD & EU test guidelines.

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

Test material

Constituent 1
Chemical structure
Reference substance name:
6-tert-butyl-2,4-xylenol
EC Number:
217-533-1
EC Name:
6-tert-butyl-2,4-xylenol
Cas Number:
1879-09-0
Molecular formula:
C12H18O
IUPAC Name:
2-tert-butyl-4,6-dimethylphenol
Test material form:
not specified
Details on test material:
PHENOL,2-(1,1-DIMETHYLETHYL)-4,6-DIMETHYL

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Not specified in the summary report.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
As per the guideline -0.5ml
Duration of treatment / exposure:
4 hour
Observation period:
72 hour
Number of animals:
Six animals (sex not specified).
Details on study design:
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits.
An additional group of three rabbits was also treated.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
3.8
Reversibility:
not fully reversible within: 72 hours. Study terminated due to toxicity.
Remarks on result:
other: Study terminated due to toxicity.
Irritant / corrosive response data:
Surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted.
No corrosive effects were noted.
Other effects:
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits resulted in the death of one animal one day after treatment. It also became necessary to kill one animal for humane reasons later the same day owing to the development of severe respiratory problems. The surviving animal showed very slight to well-defined erythema and slight oedema at the treatment site during the study. The study was terminated after the 72-hour observation. At the time it was thought that the deaths may not have been treatment-related. An additional group of three rabbits was therefore treated. One rabbit in this group was also found dead two days after treatment. The two surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted. It was concluded that the deaths seen during this study were due to the toxicity of the test material. No further animals were treated.
Based on the results of the surviving animals the test material produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results the test material was classified as irritant according to EEC labelling regulations.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as abasicforclassificationand labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).

 

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits resulted in the death of one animal one day after treatment. It also became necessary to kill one animal for humane reasons later the same day owing to the development of severe respiratory problems. The surviving animal showed very slight to well-defined erythema and slight oedema at the treatment site during the study. The study was terminated after the 72-hour observation. At the time it was thought that the deaths may not have been treatment-related. An additional group of three rabbits was therefore treated. One rabbit in this group was also found dead two days after treatment. The two surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted. It was concluded that the deaths seen during this study were due to the toxicity of the test material. No further animals were treated.

 

Based on the results of the surviving animals the test material produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The above results triggered classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). The following classification for irritant effects is therefore required:

 

Category 2 Skin Irritant

H315: Causes skin irritation 

R 38- Irritating to skin