Registration Dossier

Diss Factsheets

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:
other: Klimisch criteria

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
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