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Diss Factsheets

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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Study considered only the 4 hr timepoint, no GLP
Principles of method if other than guideline:
Primary skin irritancy test appears to have been conducted in a similar manner to current guidelines although but only one exposure period was used (4 hr) rather than 3 minute, 1 hour and 4 hours. No evidence that GLP was conformed to although it appears to have been conducted 'in the spirit' of GLP.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glutaric anhydride
EC Number:
203-593-6
EC Name:
Glutaric anhydride
Cas Number:
108-55-4
Molecular formula:
C5H6O3
IUPAC Name:
glutaric anhydride
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
7 days - observations at 5 hours, 1,2,3 and 7 days
Number of animals:
6; 3 male and 3 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 5 hours
Score:
0.8
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
1.3
Max. score:
2
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
1.8
Max. score:
2
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1.7
Max. score:
2
Remarks on result:
probability of moderate irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
7 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 5 hours
Score:
0.2
Max. score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
0.5
Max. score:
2
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
1.3
Max. score:
2
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1.2
Max. score:
2
Remarks on result:
probability of moderate irritation
Irritation parameter:
other: desquamation and necrosis
Basis:
mean
Remarks:
6 animals
Time point:
7 d
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: no quantification possible
Other effects:
Evidence of moderate necrosis observed in 2 animals at day 1 and in an additional animal at day 2. This persisted until the end of the observation period. Desquamation was also observed in all animals at day 7.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The overall scores for skin irritation (erythema and edema) observed in this study are inicative of an irritation response. Since necrosis was also observed it is clear that this substance is highly irritant. However the necrosis does not appear to have involved full thickness destruction of the skin thus it does not meet the criteria for corrosive. This substance is therefore Highly irritating.