Registration Dossier
Registration Dossier
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EC number: 202-311-9 | CAS number: 94-18-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Study of estrogenic effects on the basis of uterotrophic assay in immature SD rats treated with benzylparaben.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Details on test animals and env. conditions
TEST ANIMALS
- Source: Experimental Animal Tech Co. Of Weitonglihua (Beijing, China).
- Age at study initiation: Immature SD rats (20th Post natal day rats)
- Weight at study initiation: 61.1 ± 7.9 to 68.5 ± 6.3 g
- Fasting period before study: No data available
- Housing: two or three rats per stainless steel wire-mesh cage
- Use of restrainers for preventing ingestion (if dermal): No data available
- Diet (e.g. ad libitum): basic diet (ad libitum)
- Water (e.g. ad libitum): sufficient drinking water (ad libitum)
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available - Route of administration:
- other: Oral (Intragastric administration)
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- peanut oil
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: No data available
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - M/F ratio per cage: Not applicable
- Length of cohabitation: Not applicable
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy Not applicable
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility. Not applicable
- Further matings after two unsuccessful attempts: [no / yes (explain)] Not applicable
- After successful mating each pregnant female was caged (how): Not applicable
- Any other deviations from standard protocol: Not applicable - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 3 days (PND 21-PND 24)
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
- Remarks:
- Doses / Concentrations:
0.16, 0.8, 4, 20, and 100 mg/kg bw/day for experiment 1 0.0064 and 0.032 mg/kg bw/ day for experiment 2
Basis:
no data - No. of animals per sex per dose:
- 14 /dose
- Control animals:
- yes
- Details on study design:
- No data available
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included. No data available
DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations:Daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- No data available
- Postmortem examinations (offspring):
- No data available
- Statistics:
- One-way analysis of variance and Fisher’s least significant difference (LSD) method.
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
- Clinical signs:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Key result
- Dose descriptor:
- other: LOED (Lowest observed Effective dose)
- Effect level:
- 0.16 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Blotted Uterus weight
- Remarks on result:
- other: no other details available
- Critical effects observed:
- not specified
- Organ:
- other: not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- The endpoint for reproduction toxicity test for benzylparaben (94-18-8) was found to be LOED at 0.16 mg/kg/day.
- Executive summary:
Reproduction toxicity test was performed on SD rats from PND 21 to PND 24 days were treated with benzylparaben. The chemical was given by Intragastric route dissolve in peanut oil. On 24 PND days the rats were scarified by chloroform anesthesia 24 h after the final treatment. The uterus of all rats were dissected and blotted to study the uterotrophic effect of benzylparaben. Relative uterine weight was calculated for each animal.
After experiment it was found that the relative uterine weight was increased to 103%, 107%, 119%, 124%, 127%, 131%, and 136% that of rats in the control group.
Therefore,the endpoint for reproduction toxicity test for benzylparaben (94-18-8) was found to be LOED at 0.16 mg/kg/day.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- 0.16 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed journal
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproduction toxicity test was performed on SD rats from PND 21 to PND 24 days were treated with benzylparaben. The chemical was given by Intragastric route dissolve in peanut oil. On 24 PND days the rats were scarified by chloroform anesthesia 24 h after the final treatment. The uterus of all rats were dissected and blotted to study the uterotrophic effect of benzylparaben. Relative uterine weight was calculated for each animal.
After experiment it was found that the relative uterine weight was increased to 103%, 107%, 119%, 124%, 127%, 131%, and 136% that of rats in the control group.
Therefore,the endpoint for reproduction toxicity test for benzylparaben (94-18-8) was found to be LOED at 0.16 mg/kg/day.
Justification for selection of Effect on fertility via oral route:
The endpoint for reproduction toxicity test for benzylparaben (94-18-8) was found to be LOED at 0.16 mg/kg/day.
Effects on developmental toxicity
Description of key information
The endpoint for reproduction toxicity test for benzylparaben (94-18-8) was found to be LOED at 0.16 mg/kg/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
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
Reproduction toxicity test was performed on SD rats from PND 21 to PND 24 days were treated with benzylparaben. The chemical was given by Intragastric route dissolve in peanut oil. On 24 PND days the rats were scarified by chloroform anesthesia 24 h after the final treatment. The uterus of all rats were dissected and blotted to study the uterotrophic effect of benzylparaben. Relative uterine weight was calculated for each animal.
After experiment it was found that the relative uterine weight was increased to 103%, 107%, 119%, 124%, 127%, 131%, and 136% that of rats in the control group.
Therefore,the endpoint for reproduction toxicity test for benzylparaben (94-18-8) was found to be LOED at 0.16 mg/kg/day.
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.
