Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 411
GLP compliance:
yes
Test type:
other: 90-day repeated dose study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Formamide, purity >99%.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
other: undiluted
Doses:
0, 300, 1000, 3000 mg/kg/d, 90 days
No. of animals per sex per dose:
20
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
One substance related death (1/20) was reported at the 3000 mg/kg bw/day dose level.

Applicant's summary and conclusion

Executive summary:

Conclusion:

The acute dermal LD50 is considered to be > 3000 mg/kg bw in the rat, because low mortality (1/20 animals) was seen only in the high dose group receiving 3000 mg/kg bw/day in a dermal 90-day study conducted according to OECD TG 411 and under GLP using male and female Wistar rats (BASF; 1985).