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Key value for chemical safety assessment

Effects on fertility

Description of key information
no data
Link to relevant study records
Reference
Endpoint:
toxicity to reproduction
Remarks:
other: 28 d repeated dose study
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: GLP guideline study
Principles of method if other than guideline:
Reinblau RLW Tr. was administered by oral gavage to male and female SD rats for 28 days at dose levels of 0, 8, 40, 200, and 1000 mg/kg to asses its toxicity and reversibility. At the end of the treatment period or an additional revovery period all animals were killed at day 29 or day 43 and necropsied; gross and microscopic examination of all major organs, including reproductive organs.
GLP compliance:
yes
Species:
rat
Strain:
other: Crj:CD (SD) IGS rats (48 males and 48 females) were obtained from Charles Liver Laboratories Japan Ltd.
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: The test substance was suspended in the vehicle (0.5% CMC-Na solution)
Details on mating procedure:
not applicable
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
28 days
Frequency of treatment:
once daily in the morning for 28 days.
Details on study schedule:
6 male and 6 female rats of the control, 8, 40, 200 and 1000 mg/kg bw dose group were necropsied on day 29; additionally 6 male and 6 female rats of the control, 200, and 1000 mg/kg bw dose group were necropsied after the recovery period on day 43.
Remarks:
Doses / Concentrations:
0, 8, 40, 200, or 1000 mg/kg
Basis:
other: nominal value
No. of animals per sex per dose:
control: 6 male and 6 female rats in the control, 8, 40, 200 and 1000 mg/kg bw dose group
recovery group: 6 male and 6 female rats in the control, 200, and 1000 mg/kg bw dose group
Control animals:
yes, concurrent vehicle
Reproductive effects observed:
not specified

There were no test substance-related toxic changes in organs weight s of testis and ovaries. No histopathological changes were found in testis, ovaries and all other examined organs. Additional no changes were seen relating to in clinical signs, body weight, food consumption, hematology, blood chemistry and urinalysis.

Conclusions:
Fertility is not affected at doses of 1000 mg/kg bw for 28 days
Executive summary:

Reinblau RLW Tr. was administered by oral gavage to male and female SD rats for 28 days at dose levels of 0, 8, 40, 200, and 1000 mg/kg to asses its toxicity and reversibility. At the end of the treatment period or an additional revovery period all animals were killed at day 29 or day 43 and necropsied; gross and microscopic examination of: all major organs, including reproductive organs.

There were no test substance-related toxic changes in clinical sign, body weight, food consumption, hematology, blood chemistry, urinalysis, organ weight, necropsy, or histopathology.

No evidence of toxicity to reproductive was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOEL, rat: 1000 mg/kg bw/day).

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:
The materials/methods and results are described in detail und are sufficient for evaluation
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No evidence of toxicity to reproductive organs was observed with with 1,4-bis(2-ethyl-6-methy1anilino) anthraquinone (CAS-No. 41611-76-1) in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOEL, rat: 1000 mg/kg bw/day).


Short description of key information:
There was no fertility study with Reinlau BLW (1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone CAS 32724-62-2) available.
Due to the close structural sililarity (1,4-bis[(2,6-diethyl-4-methyl- phenyl)amino]anthraquinone (CAS-No. 32724-62-2) has an additional ethylgroup in the aromatic side chains in relation to with 1,4-bis(2-ethyl-6-methy1anilino) anthraquinone (CAS-No. 41611-76-1), the similar physicochemical and toxicological properties a read-across between the 2 compounds is justified.
No effects on reproductive organs were observed with 1,4-bis(2-ethyl-6-methy1anilino) anthraquinone (CAS-No. 41611-76-1) in a 28 day study in rats. The pathologic evaluation consisted of organ weight, gross and microscopic examination of reproductive organs, incl. tetes and ovaries. No treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination of all major organs (NOAEL, rat: 1000 mg/kg bw/day; males and females).

Justification for selection of Effect on fertility via oral route:
In a repeated dose toxicity study Reinblau RLW Tr. was administered by oral gavage to male and female SD rats for 28 days at dose levels of 0, 8, 40, 200, and 1000 mg/kg to asses its toxicity and reversibility. At the end of the treatment period or an additional revovery period all animals were killed at day 29 or day 43 and necropsied; a gross and microscopic examination of all major organs, including reproductive organs were performed.

Effects on developmental toxicity

Description of key information
no data
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

no data

Toxicity to reproduction: other studies

Additional information

no data

Justification for classification or non-classification

Based on the available study for repeated dose toxicity with with 1,4-bis(2-ethyl-6-methy1anilino) anthraquinone (CAS-No. 41611-76-1) a non-classification for fertility is justified.

This result is also valid for Reinblau BLW (1,4-bis[(2,6-diethyl-4-methyl- phenyl)amino]anthraquinone (CAS-No. 32724-62-2).

Additional information