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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
review article or handbook
Title:
Sensitization
Author:
Opdyke DLJ
Year:
1976
Bibliographic source:
Fd. cosmet. Toxicol., 14, 745-746.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
other: human maximisation test
Justification for non-LLNA method:
not available

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl malonate
EC Number:
203-305-9
EC Name:
Diethyl malonate
Cas Number:
105-53-3
Molecular formula:
C7H12O4
IUPAC Name:
diethyl malonate

In vivo test system

Test animals

Species:
human

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
4%
Challenge
Concentration / amount:
4%
No. of animals per dose:
23

Results and discussion

Positive control results:
A maximisation test according to Kligman, 1966 and Kligman and Eppstein, 1975 was reported in 23 volunteers. 4% of the test substance in petrolatum produced no sensitization reactions.

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
23
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 4%. No with. + reactions: 0.0. Total no. in groups: 23.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A human maximisation test was conducted with 23 volunteers. 4% of the test substance in petrolatum produced no sensitization reactions.