Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test item Macrolex Gelb G
Chemical name 3-Hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one
CAS no. 17772-51-9
Molecular formula C18H11NO3
Molecular mass 289.3 g/mol
Batch no. CHT23240
Appearance orange powder
Content of test item 98.8 % (not used for calculation)

Confirmation of the identity of the test item was performed.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required

Results and discussion

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

Any other information on results incl. tables

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semiocclusively for 24 hours.

A dose of 2000 mg/kg body weight was tolerated by male and female rats without toxicologically relevant clinical signs, mortalities, toxicological effects on body weight development and gross pathological findings.

Applicant's summary and conclusion

Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semiocclusively for 24 hours.

A dose of 2000 mg/kg body weight was tolerated by male and female rats without toxicologically relevant clinical signs, mortalities, toxicological effects on body weight development and gross pathological findings.