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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-Guideline study without restrictions. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
68002-97-1
Cas Number:
68002-97-1
IUPAC Name:
68002-97-1
Details on test material:
- Name of test material (as cited in study report): trade name
- Ethoxylation degree: 2
- Physical state: Slightly cloudy, colourless liquid
- Analytical purity: 100% a.i. (info by sponsor)
- Lot/batch No.: No data
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
According to Guideline.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
21 days
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0.8
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean (24,48,72 h)
Score:
0.4
Max. score:
4
Reversibility:
not fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the condition of this test classification is not justified.
Executive summary:

The effects observed are not increasing, but rather point to a slower recovery and with scores of 1 or 2. Additionally, the gross pathology does not present thickening, ulcer, superficial blistering, hyperkeratosis or flaking during healing.

Hence, the effects seen are closer to a mild irritant than one with a clear R38. Due to the fact that all other tested members of this category do not show a skin irritating potential under the correct test conditions, these effects do not justify the classification R38.