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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A read-across study with an analogous substance was scientifically justified, because the target substance is the major component, and the central member of an homologous series of components, of the source substances, possessing identical functional groups and extremely similar structures. It is reasonable to expect that the toxicological properties of the target and source substances will not be markedly different. On this basis, experimental data on the source substances are expected to be directly applicable to the target substance, and can be used to adequately predict its properties. Further details are provided in an attached document to the acute toxicity endpoint summary.

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
Details on test material:
30-36% active matter

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
according to guideline
Statistics:
according to guideline

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
normal development
Gross pathology:
no abnormalities
Other findings:
slight edema (grade 1)

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw
Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats(5 males and 5 females)were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item L-Glutamic acid, N-coco acylderivs., disodiumsalts to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

 

  • No mortality occurred

  • No signs of systemic toxicity were observed

  • The following test item-related local effects were recorded during the course of the study:

 

o  Very slight erythema (grade 1)

 

  • 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.

 


Accordingly, the acute dermal median lethal dose (LD50) was determined to be
LD50, dermal, rat > 5000 mg/kg bw