Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five male and five female Wistar rats (158-182 g) received a single dose of 5000 mg/kg bw of Bayplast Gelb 5G per gavage. The animals were observed for mortality, body weights and clinical signs through day 14. A gross necropsy was performed on animals sacrificed at the end of the 14 days observation period.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Bayplast Gelb 5G

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats/dose
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No signs of intoxication were seen after the application of 5000 mg/kg bw to male and female rats. None of the animals died. Weight gain was not influenced.

None of the animals sacrificed at the end of study showed any noticable gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

Five male and five female Wistar rats (158-182 g) received a single dose of 5000 mg/kg bw of Bayplast Gelb 5G per gavage. The animals were observed for mortality, body weights and clinical signs through day 14. A gross necropsy was performed on animals sacrificed at the end of the 14 days observation period.

No signs of intoxication were seen after the application of 5000 mg/kg bw to male and female rats. None of the animals died. Weight gain was not influenced. None of the animals sacrificed at the end of study showed any noticable gross pathological findings.

LD50 > 5000 mg/kg bw (rat, male + female)