Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Pre-natal development toxicity study
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 87/302/EWG, S24; OECD 414
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar Chbb:THOM (SPF)
Sex:
female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil
Details on exposure:
Method of administration or exposure : stomach probe.
Analytical verification of doses or concentrations:
not specified
Frequency of treatment:
Dosing regime : 7 days/week
No. of animals per sex per dose:
Number of dams and doses
25 at 0mg/kg or mg/l
25 at 100 mg/kg or mg/l
25 at 400 mg/kg or mg/l
25 at 1000 mg/kg or mg/l

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
female
Basis for effect level:
other: Original NCD unit is mg/kg/day (0 mg/l/day)
Remarks on result:
other: Generation: maternal toxicity (migrated information)
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day (0 mg/l/day)
Remarks on result:
other: Generation: embriotoxicity (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Details on maternal toxic effects : No substance related effects.

Details on embryotoxic/teratogenic effects :

Effects on fetus - gross : No substance related effects.

Effects on fetus - soft tissue : No substance related effects.

Effects on fetus - skeletal : No substance related effects.

Applicant's summary and conclusion

Conclusions:
The NOAEL of ethylhexyltriazone in rats for maternal toxicity is 1000 mg/kg bw/day (nominal).
The NOAEL of ethylhexyltriazone in rats for embriotoxicity is 1000 mg/kg bw/day (nominal).