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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
L-Glutamic acid, N-coco acyl derivs., disodium salts
EC Number:
269-085-1
EC Name:
L-Glutamic acid, N-coco acyl derivs., disodium salts
Cas Number:
68187-30-4
IUPAC Name:
L-glutamic acid, N-coco acyl derivs., disodium salts
Test material form:
solid
Details on test material:
Organic

Test animals

Species:
rat
Strain:
other: Crl:WI (Han) SPF
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
On clipped skin (dorsal and dorso-lateral parts of the trunk)
The application area covered at least 10% of the total body surface area
Duration of exposure:
24 hours
The animals were then observed for 14 days.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
According to guideline
Statistics:
According to guideline

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: No signs of systemic toxicity were observed.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
Other findings:
A very slight edema (grade 1) was observed.

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the acute dermal LD50 of the substance in rats was determined to be >5000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the substance according to OECD Guideline 402, in compliance with GLP. Male and female Crl:WI (Han) SPF rats were exposed 5000 mg/kg bw of the test substance to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 h. The application area covered at least 10% of the total body surface area. The animals were observed for 14 d. No mortality occurred during the study. No signs of systemic toxicity were observed. The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study but a very slight edema (grade 1) was observed. Under the study conditions, the acute dermal LD50 of the substance in rats was determined to be >5000 mg/kg bw (BASF SE, 2013).