Reaction mass of sodium 4-chloro-5-alkylbenzotriazolide and sodium 5-chloro-4-alkylbenzotriazolide and sodium 4-chloro-7-alkylbenzotriazolide and sodium 5-chloro-6-alkylbenzotriazolide

Endpoint summary

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)

Deviations:

no

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Type of inhalation exposure (if applicable):

whole body

See attachment:
Tables 1, 2 and 3, 12-24 and 25
Appendix 1-6, 11-14, 21 and 24
Annex 3

Dose descriptor:

NOAEL

Effect level:

<= 300 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: for offspring growth, based on the low birthweight and low bodyweight gain seen in litters where the females were dosed at 1000 mg/kg/day

Remarks on result:

other: Generation: F0 (migrated information)

The mean number of implantations, the live litter size on Day 1, the offspring survival up to
Day 7 of age and sex ratio showed no adverse effect of parental treatment. Offspring
bodyweight on Day 1 of age and subsequent bodyweight gain up to Day 7 of age were similar
to control values for the litters of females receiving CI-166 at 100 and 300 mg/kg/day but
were significantly lower at 1000 mg/kg/day. Macroscopic examination of offspring killed at
scheduled termination on Day 7 of age revealed no abnormality.

See attachment:
Appendix 15-23
Tables 19-23 and Figure 5

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

<= 1 000 mg/kg bw/day

Based on:

dissolved

Sex:

male/female

Basis for effect level:

other: For reproductive performance in the CD rat following oral gavage administration in a standard screening test.

Reproductive effects observed:

not specified

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

High quality study (Klimish: 1)