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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 1

Data source

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

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
Test material form:
other: liquid
Details on test material:
active matter: 33.3%

Test animals

Species:
rat
Strain:
other: Crl:WI (Han) SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
5 m / 5 f per dose

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 m / 5 f
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: active matter 33%
Mortality:
none
Clinical signs:
other: erythema grade 1-4, edema grade 1-4, incrustations, scaling
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at
the end of the study.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw, not taking into consideration the active matter content.
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 D-Glucopyranose, 6-O-(carboxymethyl)-, Oligomer, C12-14-alkyl glycosidet, sodium salt (active matter 33%) 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 clinical findings were observed · The following test item-related local effects were recorded during the course of the study: Erythema grade 1 to 4, Edema grade 1 to 4, Incrustations, Incrustations partly detached, Scaling · The mean body weight of the animals increased within the normal range throughout the study period. · 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 (active matter 33%). A final conclusion on the classification can not be made based on this result.