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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Principles of method if other than guideline:
5 male and 5 female Wistar rats were treated occlusively with a single application of 2000 mg/kg bw of Pigment Yellow FC 26290. The animals were observed for mortality, body weights and clinical signs through day 14. Gross pathological examinations were done on all animals sacrificed at the end of study. Necropsy records were prepared for all animals.
GLP compliance:
yes
Test type:
other: singe application of 2000 mg/kg bw

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
content: 83.9%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and five female animals/dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No signs of systemic poisoning were observed. As a local skin change slight reddening at the application site was temporarily observed in some single animals. Three females showed a slight decrease in body weight during the 2nd study week. Growth of all the other males and females was not affected. No deaths occured. None of the animals sacrificed at the end of the 14-day observation period showed any noticable gross pathological findings.

Applicant's summary and conclusion

Executive summary:

5 male and 5 female Wistar rats were treated occlusively with a single application of 2000 mg/kg bw of Pigment Yellow FC 26290. The animals were observed for mortality, body weights and clinical signs through day 14. Gross pathological examinations were done on all animals sacrificed at the end of study. Necropsy records were prepared for all animals.

No signs of systemic poisoning were observed. As a local skin change slight decrease in body weight during the 2nd study week. Growth of all the other males and females was not affected. No deaths occured. None of the animals sacrificed at the end of the 14 -day observation period showed any noticable gross pathological findings.

The LD50 for male and female rats was greater than 2000 mg/kg body weight and was not exactly determined