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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:
comparable to guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Scoring system
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pivaloyl chloride
EC Number:
221-921-6
EC Name:
Pivaloyl chloride
Cas Number:
3282-30-2
Molecular formula:
C5H9ClO
IUPAC Name:
2,2-dimethylpropanoyl chloride
Details on test material:
Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 99% on the MSDS.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
21 days
Number of animals:
6 (3 per sex)
Details on study design:
Undiluted test material was placed on clipped skin under a gauze patch. Each patch was secured with a strip of non-irritating adhesive tape and the entire trunk of the animal was wrapped with a semi-permeable dressing.
The dressings were removed 4 hours later and the skin was gently wiped with a moist cloth to remove as much residual material as possible.

SCORING SYSTEM
The animals were scored for erythema and eschar formation, edema formation and any other dermal effects or irritation at 1, 24, 48, and 72 hours and 4, 7, 10, 14, 17 and 21 days after removal of the dressings. The maximum score for each endpoint was 4 for each observation. All of the erythema and edema scores for each observation point were added together, and the sum was divided by the number of animals observed to determine an irritation score. The maximum irritation score was selected from the observation time yielding the highest irritation score.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Score:
6
Remarks on result:
other:
Remarks:
Erythema and edema were present at each observation time through Day 21.

Any other information on results incl. tables

Erythema and edema were present at each observation time through Day 21. The maximum irritation score was 7.0/8.0 on Day 7 (which would lead to a classification of severe irritant). Since necrosis was present on the test sites of all 6 animals, the test material was given a descriptive rating of corrosive.

Applicant's summary and conclusion

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