Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically valid. Adopted according to OECD SIDS (public available peer reviewed source).

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1962
Reference Type:
publication
Title:
Range finding toxicity data. (List VII).
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani US, Striegel JA and Nycum JS.
Year:
1969
Bibliographic source:
Am. Ind. Hyg. Assoc., 30:470-476.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: According to 24-hour cuff method of Draize et al. 1944
Principles of method if other than guideline:
The LD50 was determined by a method closely akin to the one-day cuff method of Draize et al. (1944) using groups of 4 male albino New Zealand rabbits. The fur was removed by clipping and the dose was retained beneath an impervious plastic film (i.e. occlusive). The animals were immobilized/exposed for 24 hours. Afterwards, the film was removed and the animals were observed for 14 days.
GLP compliance:
no
Test type:
standard acute method

Test material

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
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male

Administration / exposure

Type of coverage:
occlusive
No. of animals per sex per dose:
4 per dose

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 960 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It can be concluded based on the study results that the acute dermal toxicity is > 16960 mg/kg bw and thus far above the limit for a classification according to GHS criteria.