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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
two-generation reproductive toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
Deviations:
yes
Remarks:
Only 3 applications per week; no or only partial examination of oestrous cycle and sperm parameters.
GLP compliance:
no
Limit test:
no
Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
As described in guideline.
Route of administration:
dermal
Vehicle:
water
Details on exposure:
Dose volume: 1 mL/kg bw
Details on mating procedure:
As described in guideline.
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
No data.
Frequency of treatment:
3/week (except during mating)
Details on study schedule:
P: 119 days of dosing
F1: 133 days of dosing
Dose / conc.:
0 other: % nominal in water
Dose / conc.:
1 other: % nominal in water
Dose / conc.:
10 other: % nominal in water
Dose / conc.:
25 other: % nominal in water
Dose / conc.:
0 other: mg/kg bw/day nominal in water
Dose / conc.:
10 other: mg/kg bw/day nominal in water
Dose / conc.:
100 other: mg/kg bw/day nominal in water
Dose / conc.:
250 other: mg/kg bw/day nominal in water
No. of animals per sex per dose:
30 (P)
20/40 (male/female; F1)
Control animals:
yes, concurrent vehicle
Parental animals: Observations and examinations:
As described in guideline.
Oestrous cyclicity (parental animals):
Not examined.
Sperm parameters (parental animals):
Weight and histopathology are missing.
Litter observations:
No individual weighing of pups.
Postmortem examinations (parental animals):
As described in guideline.
Postmortem examinations (offspring):
As described in guideline.
Clinical signs:
no effects observed
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
no effects observed
Reproductive function: oestrous cycle:
not examined
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed
In the highest dose, body weights of both males and females in both treated generations were sporadically and not always statistically significant decreased compared to controls.
At necropsy organ weight differences in liver, lung, kidney and heart were observed in the F1 generation, but no pathological findings were associated with the affected organs.
Dose descriptor:
NOAEL
Remarks:
reproduction
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: No treatment-related effects observed.
Dose descriptor:
NOAEL
Remarks:
development
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: No treatment-related effects observed.
Dose descriptor:
NOEL
Remarks:
systemic
Effect level:
100 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: Changes in body weight and organ weights without associated pathological findings.
Dose descriptor:
NOAEL
Remarks:
systemic
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: Changes in body weight and organ weights without associated pathological findings.
Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed
Dose descriptor:
NOAEL
Remarks:
reproduction
Generation:
F1
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related effects observed.
Dose descriptor:
NOAEL
Remarks:
development
Generation:
F1
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related effects observed.
Dose descriptor:
NOAEL
Remarks:
development
Generation:
F2
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related effects observed.
Reproductive effects observed:
not specified

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD 416
Deviations:
yes
Remarks:
Only 3 applications per week; no or only partial examination of oestrous cycle and spermatogenicity.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
EC Number:
614-482-0
Cas Number:
68439-46-3

Test animals

Species:
rat
Strain:
Fischer 344
Details on test animals or test system and environmental conditions:
As described in guideline.

Administration / exposure

Route of administration:
dermal
Vehicle:
water
Details on exposure:
Dose volume: 1 mL/kg bw
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
As described in guideline.
Duration of treatment / exposure:
No data.
Frequency of treatment:
3/week (except during mating)
Duration of test:
From Day 0 of gestation until weaning.
Doses / concentrationsopen allclose all
Dose / conc.:
0 other: % nominal in water
Dose / conc.:
1 other: % nominal in water
Dose / conc.:
10 other: % nominal in water
Dose / conc.:
25 other: % nominal in water
Dose / conc.:
0 other: mg/kg bw/day nominal in water
Dose / conc.:
10 other: mg/kg bw/day nominal in water
Dose / conc.:
100 other: mg/kg bw/day nominal in water
Dose / conc.:
250 other: mg/kg bw/day nominal in water
No. of animals per sex per dose:
30 (P)
20/40 (male/female; F1)
Control animals:
yes, concurrent vehicle

Examinations

Maternal examinations:
As described in guideline.
Ovaries and uterine content:
As described in guideline.
Fetal examinations:
As described in guideline.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
In the highest dose, body weights of both males and females in both treated generations were sporadically and not always statistically significant decreased compared to controls.
At necropsy organ weight differences in liver, lung, kidney and heart were observed in the F1 generation, but no pathological findings were associated with the affected organs.

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
act. ingr.
Basis for effect level:
other: developmental toxicity
Dose descriptor:
NOEL
Effect level:
100 mg/kg bw/day (nominal)
Based on:
act. ingr.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
act. ingr.
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
>= 250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related effects observed.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion