2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

based on test type (migrated information)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Japanese study, tables and results are available in english, narrative part not translated

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Deviations:

not specified

GLP compliance:

not specified

Remarks:

GLP compliance expected

Test material

Test material information

Constituent 1

Reference substance name:

2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol

EC Number:

223-383-8

EC Name:

2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol

Cas Number:

3864-99-1

IUPAC Name:

2,4-di-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)phenol

Test material form:

not specified

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: gum arabicum

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

up to 28 consecutive days

Frequency of treatment:

once daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 2.2, 25, 250 mg/kg/day
Basis:
nominal conc.

No. of animals per sex per dose:

15 (control and high dose groups)
10 (low and mid dose groups)

Control animals:

yes, concurrent vehicle

Examinations

Parental animals: Observations and examinations:

clinical observations, body weight, food consumption, clinical pathology

Oestrous cyclicity (parental animals):

no

Sperm parameters (parental animals):

general histopathologic testes investigation

Litter observations:

basic analysis

Postmortem examinations (parental animals):

organ weights, histopathologic examinations

Postmortem examinations (offspring):

none

Reproductive indices:

implantation and gestation indices, live birth index

Offspring viability indices:

numbers, sex ratio, viability index

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

The following effects occurred in males only: Increase in album, in A/G ratio, decrease in alpha-2-globuline, beta-globuline as well as increase in absolute and relative liver weight. The liver weight increase showed a clear trend towards reversibility but was not completely reversible after the 14-day recovery period.

Effect levels (P0)

1

Dose descriptor:

NOEL

Effect level:

2.5 mg/kg bw/day

Based on:

test mat.

Sex:

male

Basis for effect level:

other: liver weight increase and imbalance of protein pattern

2

Dose descriptor:

NOAEL

Effect level:

250 mg/kg bw/day

Based on:

test mat.

Sex:

female

Basis for effect level:

other: reproductive parameters

Results: F1 generation

Details on results (F1)

No adverse findings detected.

Effect levels (F1)

Dose descriptor:

NOEL

Generation:

F1

Effect level:

250 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: developmental parameters

Overall reproductive toxicity

Reproductive effects observed:

not specified