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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline-similar study published in a peer-reviewed journal. The publication details and summarises results for circa 110 organic and inorganic materials for whch acute tests were completed prior to introduction of formal test guidelines. The conducting institute - Mellon Institute for Industrial Research or Carnegie-Mellon Institute of Research is a recognised unit publishing peer-reviewed data of reliable quality.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity was calculated using a technique similar to the one-day cuff method of Draize.
GLP compliance:
no
Remarks:
Study conducted prior to establishment of GLP guidelines
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Fumaric acid
EC Number:
203-743-0
EC Name:
Fumaric acid
Cas Number:
110-17-8
Molecular formula:
C4H4O4
IUPAC Name:
but-2-enedioic acid
Details on test material:
Only the common name provided in publication

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
female
Details on test animals or test system and environmental conditions:
Rabbits weighed between 3 and 4 kg and were maintained on Purina Rabbit Chow.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Fur was removed from the entire trunk by clipping and the doses kept in place using 8-ply gauze patches under a latex rubber film.
Duration of exposure:
24 hrs
Doses:
The doses were arranged in a logarithmic series differing by a factor of two.
No. of animals per sex per dose:
3 females/dose
Control animals:
not specified
Details on study design:
Single dose dermal toxicity was determined by the method of Smyth et al, 1962. Based upon mortalities during the 14-day observation period, the most probable LD50 value was estimated using a moving average interpolation method or probit where sufficient data existed. . The 95% confidence limits were estimated by the moving average technique.
Statistics:
Moving average interpolation or probit analysis

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
20 000 mg/kg bw
Mortality:
No data
Clinical signs:
other: No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This study supports the conclusion that fumaric acid is of very low acute dermal toxicity and would not require classification for dermal toxicity under EU, CLP or GHS systems.
Executive summary:

Single dose dermal toxicity of fumaric acid using female New Zealand albino rabbits was reported as 20000 mg/kg.