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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

The no-observed-aclverse-effect level (NOAEL) of Disperse Blue 077 was judged to be 1000 mg/kg/day for reproductive and developmental toxicity because no changes were observed in reproductive function.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: 0.5 % (w /v)methylcellulose (MC) solution
Duration of treatment / exposure:
42 days
Frequency of treatment:
daily
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
40 mg/kg bw/day
Dose / conc.:
200 mg/kg bw/day
Dose / conc.:
1 000 mg/kg bw/day
Control animals:
yes, concurrent vehicle
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Other effects:
no effects observed
Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: overall effects
Critical effects observed:
no
No general or systemic toxicity was seen in treated males and females. No test article-related changes were observed in estrous cycle examination, copulation rate, copulatory interval, fertility rate, gestation index, gestation period, number of corpora lutea, number of implantations, implantation index, live birth index, delivery index, or nursing behavior in any test article group.
Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: overall no effects observed
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Critical effects observed:
no
Key result
Reproductive effects observed:
no
Conclusions:
The no-observed-aclverse-effect level (NOAEL)of Disperse Blue 77 was judged to be 1000 mg/kg/day for reproductive and developmental toxicity because no changes were observed in reproductive function or in any pup.
Executive summary:

Disperse Blue 077 was evaluated for reproductive and developmental toxicity in a study conducted according OECD to TG 422. In this study, the test substance was repeatedly administered  orally  to  12 Crl:CD(SD) male rats (10 weeks old at the initiation of dosing) per group at dose levels of 0 [0.5 w/v% methylcellulose (MC) solution], 40, 200, and 1000 mg/kg/day once daily for 14 days. The animals were then mated to observe reproductive ability, and the toxic changes induced over 42-day repeated oral administration were evaluated. Disperse Blue 77 was also repeatedly administered orally to 12 Crl:CD(SD) female rats (10 weeks old at the initiation of dosing) per group at the same dose levels as males from 14 days before mating through the mating and gestation periods until Day 4 of lactation to evaluate reproductive ability and viability and development of pups. For the control and 1000 mg/kg groups, a 2-week recovery period was set to follow the 42-day repeated oral administration, to assess the reversibility of the toxicity. No animal died in any test article group. No general or systemic toxicity was seen in treated males and females. No test article-related changes were observed in estrous cycle examination, copulation rate, copulatory interval, fertility rate, gestation index, gestation period, number of corpora lutea, number of implantations, implantation index, live birth index, delivery index, or nursing behavior in any test article group. With respect to examinations of pups, no test article-related changes were noted in the number of pups delivered, number of live pups, live birth index, viability index or sex ratio on Day 0 after birth, number of live pups, viability index or sex ratio on Day 4 after birth, clinical signs, external examinations, body weight, or necropsy. Accordingly, it is considered that the test article does not affect the development or growth of next generation. From these results, under the conditions of  this study,  the no-observed-aclverse-effect level (NOAEL) of Disperse Blue 077 was judged to be 1000 mg/kg/day for reproductive and developmental toxicity because no changes were observed in reproductive function or in any pup.

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:
Good quality study, however only an English abstract is available. The full study report is currently availabe in Japanese language only.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Disperse Blue 077 was evaluated for reproductive and developmental toxicity in rats in a study conducted according OECD to TG 422. No animal died in any test article group. No general or systemic toxicity was seen in treated males and females. No test article-related changes were observed in estrous cycle examination, copulation rate, copulatory interval, fertility rate, gestation index, gestation period, number of corpora lutea, number of implantations, implantation index, live birth index, delivery index, or nursing behavior in any test article group. With respect to examinations of pups, no test article-related changes were noted in the number of pups delivered, number of live pups, live birth index, viability index or sex ratio on Day 0 after birth, number of live pups, viability index or sex ratio on Day 4 after birth, clinical signs, external examinations, body weight, or necropsy. Accordingly, it is considered that the test article does not affect the development or growth of next generation. From these results, under the conditions of  this study,  the no-observed-aclverse-effect level (NOAEL) of Disperse Blue 077 was judged to be 1000 mg/kg/day for reproductive and developmental toxicity because no changes were observed in reproductive function or in any pup.

Effects on developmental toxicity

Description of key information

The no-observed-aclverse-effecl level (NOAEL) of Disperse Blue 077 was judged to be 1000 mg/kg/day for developmental toxicity.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only abstract in English available; full study report currently published in Japanese language only
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
other: Crl:CD(SD)
Route of administration:
oral: gavage
Vehicle:
other: 0.5 % (w/v) methylcellulose (MC) solution
Duration of treatment / exposure:
42 days
Frequency of treatment:
daily
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
40 mg/kg bw/day
Dose / conc.:
200 mg/kg bw/day
Dose / conc.:
1 000 mg/kg bw/day
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Abnormalities:
no effects observed
Fetal body weight changes:
no effects observed
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
no effects observed
Changes in litter size and weights:
no effects observed
Changes in postnatal survival:
no effects observed
External malformations:
no effects observed
Skeletal malformations:
no effects observed
Visceral malformations:
no effects observed
Other effects:
no effects observed
Details on embryotoxic / teratogenic effects:
no test article related changes were noted in the number of pups delivered, number of live pups, live birth index, viability index or sex ratio on Day 0 after birth, number of live pups, viability index or sex ratio on Day 4 after birth, clinical signs, external examinations, body weight, or necropsy.
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Conclusions:
The no-observed-aclverse-effect level (NOAEL) of Disperse Blue 077 was judged to be 1000 mg/kg/day for reproductive and developmental toxicity because no changes were observed in reproductive function or in any pup.
Executive summary:

Disperse Blue 077 was evaluated for reproductive and developmental toxicity in a study conducted according OECD to TG 422. In this study, the test substance was repeatedly administered orally to 12 Crl:CD(SD) male rats (10 weeks old at the initiation of dosing) per group at dose levels of 0 [0.5 w/v % methylcellulose (MC) solution], 40, 200, and 1000 mg/kg/day once daily for 14 days. The animals were then mated to observe reproductive ability, and the toxic changes induced over 42-day repeated oral administration were evaluated. Disperse Blue 77 was also repeatedly administered orally to 12 Crl:CD(SD) female rats (10 weeks old at the initiation of dosing) per group at the same dose levels as males from 14 days before mating through the mating and gestation periods until Day 4 of lactation to evaluate reproductive ability and viability and development of pups. For the control and 1000 mg/kg groups, a 2-week recovery period was set to follow the 42-day repeated oral administration, to assess the reversibility of the toxicity. No animal died in any test article group. No general or systemic toxicity was seen in treated males and females. No test article-related changes were observed in estrous cycle examination, copulation rate, copulatory interval, fertility rate, gestation index, gestation period, number of corpora lutea, number of implantations, implantation index, live birth index, delivery index, or nursing behavior in any test article group. With respect to examinations of pups, no test article related changes were noted in the number of pups delivered, number of live pups, live birth index, viability index or sex ratio on Day 0 after birth, number of live pups, viability index or sex ratio on Day 4 after birth, clinical signs, external examinations, body weight, or necropsy. Accordingly, it is considered that the test article does not affect the development or growth of next generation. From these results, under the conditions of this study, the no-observed-aclverse-effect level (NOAEL) of Disperse Blue 077 was judged to be 1000 mg/kg/day for reproductive and developmental toxicity because no changes were observed in reproductive function or in any pup.

Effect on developmental toxicity: 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:
Good quality study, however only an abstract in English is available, while the full study report is currently published in Japanese language only.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information