Registration Dossier
Registration Dossier
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EC number: 942-982-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
REACH Annex VIII requires that, if there is no evidence from available information that the substance may be a developmental toxicant, a reproductive toxicity test involving screening for developmental toxicity should be conducted. Data from a reliable (Klimisch 2) OECD422 repeated dose and reproductive/developmental toxicity study in the rat using the read-across substance was available. This study involved oral gavage administration of the source substance at dose levels of 0, 250, 500 and 1000 mg/kg/day to males for 46 days from a4 days prior to mating, and to females for 41 -45 days from 14 days prior to mating to ay 4 post partum throughout mating and pregnancy. There were no signs of an effect of treatement on either the parental (P0) animals or on the F1 offspring and the NOAEL for both reproductive and developmental effects was considered to be >/=1000 mg/kg/day.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to OECD 422 (Peer review was conducted by a Japanese toxicological expert group at March 5, 2001; However only secondary source material available)
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- other: Crj; CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 4 d
- Proof of pregnancy: vaginal plug or sperm in vaginal smear - Duration of treatment / exposure:
- Exposure period: male: 46 days from 14 days prior to mating; female: 41-45 days from 14 days prior to mating to day 4 postpartum throughout mating and pregnancy
Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: male: 47 days; female: 42-46 days - Frequency of treatment:
- Once daily
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000 mg/kg bw/ day (males & females)
Basis: - No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: 1, 2, 3, 5, 7, 10 and 14 d; then weekly
BODY WEIGHT: Yes
- Time schedule for examinations: 1, 2, 3, 5, 7, 10 and 14 d; then weekly
- Oestrous cyclicity (parental animals):
- Estrous cycle was determined before mating
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, viability index, body weight and necroscopy
- Postmortem examinations (parental animals):
- GROSS NECROPSY
ORGAN WEIGHTS - Reproductive indices:
- Estrous cycle, copulation index (number of pairs with successful copulation/number of pairs mated X 100), fertility index (number of pregnant animals/number of pairs with successful copulation X 100), gestation index (number of females with live pups/number of living pregnant females X 100), gestation length, nursing index, number of pregnant females, corpora lutea and implantation sites, implantation index (number of implantation sites/number of corpora lutea X 100), delivery index (number of pups born/number of implantation sites X 100),
- Offspring viability indices:
- number of live pups on day 4/number of live pups on day 0 X 100
- 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
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: not reported
- Clinical signs:
- no effects observed
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: not reported
- Reproductive effects observed:
- not specified
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to OECD 422 (Peer review was conducted by a Japanese toxicological expert group at March 5, 2001; However only secondary source material available)
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under ‘Attached justification’ in Section 13 of IUCLID and under ‘Cross-reference’ in the IUCLID Robust Study Summary. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- other: Crj; CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 4 d
- Proof of pregnancy: vaginal plug or sperm in vaginal smear - Duration of treatment / exposure:
- Exposure period: male: 46 days from 14 days prior to mating; female: 41-45 days from 14 days prior to mating to day 4 postpartum throughout mating and pregnancy
Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: male: 47 days; female: 42-46 days - Frequency of treatment:
- Once daily
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000 mg/kg bw/ day (males & females)
Basis: - No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: 1, 2, 3, 5, 7, 10 and 14 d; then weekly
BODY WEIGHT: Yes
- Time schedule for examinations: 1, 2, 3, 5, 7, 10 and 14 d; then weekly
- Oestrous cyclicity (parental animals):
- Estrous cycle was determined before mating
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, viability index, body weight and necroscopy
- Postmortem examinations (parental animals):
- GROSS NECROPSY
ORGAN WEIGHTS - Reproductive indices:
- Estrous cycle, copulation index (number of pairs with successful copulation/number of pairs mated X 100), fertility index (number of pregnant animals/number of pairs with successful copulation X 100), gestation index (number of females with live pups/number of living pregnant females X 100), gestation length, nursing index, number of pregnant females, corpora lutea and implantation sites, implantation index (number of implantation sites/number of corpora lutea X 100), delivery index (number of pups born/number of implantation sites X 100),
- Offspring viability indices:
- number of live pups on day 4/number of live pups on day 0 X 100
- 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
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: not reported
- Clinical signs:
- no effects observed
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: not reported
- Reproductive effects observed:
- not specified
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
REACH Annex VIII requires that, if there is no evidence from available information that the substance may be a developmental toxicant, a reproductive toxicity test involving screening for developmental toxicity should be conducted. Data from a reliable (Klimisch 2) OECD422 repeated dose and reproductive/developmental toxicity study in the rat using the read-across substance was available. This study involved oral gavage administration of the source substance at dose levels of 0, 250, 500 and 1000 mg/kg/day to males for 46 days from a4 days prior to mating, and to females for 41 -45 days from 14 days prior to mating to ay 4 post partum throughout mating and pregnancy. There were no signs of an effect of treatment on either the parental (P0) animals or on the F1 offspring and the NOAEL for both reproductive and developmental effects was considered to be >/=1000 mg/kg/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
