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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database.

Data source

Reference
Reference Type:
other: authoritative database
Title:
Single oral administration toxicity test
Author:
Ministry of Health
Year:
2010
Bibliographic source:
J-CHECK

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity of 1,2-di(ethenyl)benzene (CAS no: 1321-74-0) in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Divinylbenzene
EC Number:
215-325-5
EC Name:
Divinylbenzene
Cas Number:
1321-74-0
Molecular formula:
C10H10
IUPAC Name:
1,2-di(ethenyl)benzene
Details on test material:
- IUPAC Name: 1,2-di(ethenyl)benzene- Common Name: Divinylbenzene- InChI: 1S/C10H10/c1-3-9-7-5-6-8-10(9)4-2/h3-8H,1-2H2- Smiles: C=Cc1ccccc1C=C- Molecular formula :C10H10- Molecular weight :131.1969 g/mol- Substance type:Organic- Physical state:colorless or pale yellow transparent liquid- Purity:96.2%- Impurities (identity and concentrations):Ethyl vinyl benzene as impurity 3.2 wt%, p-tert-butyl catechol as 1010 ppm and others as 0.6 wt%
Specific details on test material used for the study:
- IUPAC Name: 1,2-di(ethenyl)benzene- Common Name: Divinylbenzene- InChI: 1S/C10H10/c1-3-9-7-5-6-8-10(9)4-2/h3-8H,1-2H2- Smiles: C=Cc1ccccc1C=C- Molecular formula :C10H10- Molecular weight :131.1969 g/mol- Substance type:Organic- Physical state:colorless or pale yellow transparent liquid- Purity:96.2%- Impurities (identity and concentrations):Ethyl vinyl benzene as impurity 3.2 wt%, p-tert-butyl catechol as 1010 ppm and others as 0.6 wt%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
[Crj: CD (SD) IGS, (SPF)]
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Charles River Japan.- Age at study initiation: 4 week old- Weight at study initiation: Body weight ranged from 112 to 120 g for males and 95 to 103 g for females.- Fasting period before study: Animals were fasted for about 20 hours from the evening on the day before administration to about 6 hours after the administration and from the time of grouping until about 6 hours after administration.- Housing: stainless steel cages were used to house up to 5 animals per cage and after grouping they were individually raised using a stainless steel cage.- Diet (e.g. ad libitum): free -fed by solid feed, ad libitum.- Water (e.g. ad libitum): drinking water was freely ingested in tap water, ad libitum.- Acclimation period: The obtained animals were subjected to a 5-day quarantine period and then 3 days ofacclimation period.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20 to 24 ° C.- Humidity (%): 40 to 70%- Air changes (per hr): ventilation frequency 12 times / hour- Photoperiod (hrs dark / hrs light): light and dark each for 12 hours (lighting: 6 am to 6 pm).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE- Amount of vehicle (if gavage): 10 mL/kg
Doses:
0, 500, 1000, 2000 mg/kg
No. of animals per sex per dose:
Total = 30 animals (5 male and 5 female per group)
Control animals:
yes
Remarks:
Total = 10 (5 male and 5 female)
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations: The general condition and the presence or absence of death were observed once a day until the administration day before administration and 6 hours after administration (30 minutes after administration, 2, 4 and 6 hours after administration), and during the observation period from the day after administration; Weighing: Measurement was made on the administration day and at 1, 3, 7, 10 and 14 days after administration.- Necropsy of survivors performed: yes, at the end of the observation period, necropsy was done after exsanguination of the abdominal aorta from the abdominal aorta under ether anesthesia and then necropsied.
Statistics:
For body weight, average values and standard deviations were calculated for each group. Significant difference test was performed using Dunnett's multiple comparison tests between control group and each administration group.

Results and discussion

Preliminary study:
In the preliminary tests using the male rats previously conducted (administration stage: 0, 125, 500, and 2000 mg/kg), the dose was not decreased even when 2000 mg/kg was administered, and the dose decreased, only a low value of body weight was recognized. Therefore, in this study, 2000 mg/kg was set as high dose, and 1000 and 500 mg/kg were set as the common ratio 2 below. As a control, a group to which only the vehicle (corn oil) of the same volume as the administration liquid of the test substance administration group was administered was provided.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed in both sexes.
Clinical signs:
other: In the observation of the general condition, a decline in locomotor activity was observed in 2 to 6 hours after administration in both sexes in the 2000 mg/kg group. Besides, diarrhea was observed in each group including females of the control group, but
Gross pathology:
There was no abnormality in both sexes.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) was considered to be >2000 mg/kg bw, when groups of 5 male and 5 female Sprague-Dawley [Crj: CD (SD) IGS, (SPF)] rats were treated with 1,2-di(ethenyl)benzene (CAS no: 1321-74-0) via oral gavage route.
Executive summary:

The acute oral toxicity study was conducted by using 1,2-di(ethenyl)benzene (CAS no: 1321-74-0) in groups of 5 male and 5 female Sprague-Dawley [Crj: CD (SD) IGS, (SPF)] rats at the dose concentration of0, 500, 1000, 2000 mg/kg bw. The given test chemical (Lot No. SXS2; purity: 96.2%, with ethyl vinyl benzene as impurity 3.2 wt%, p-tert-butyl catechol as 1010 ppm and others as 0.6 wt%) was prepared by dilution with corn oil and administered as 10 mL/kg via oral gavage route. In the preliminary tests using the male rats previously conducted (administration stage: 0, 125, 500, and 2000 mg/kg), the dose was not decreased even when 2000 mg/kg was administered, and the dose decreased, only a low value of body weight was recognized. Therefore, in this study, 2000 mg/kg was set as high dose, and 1000 and 500 mg/kg were set as the common ratio 2 below. As a control, a group to which only the vehicle (corn oil) of the same volume as the administration liquid of the test substance administration group was administered was provided. The general condition and the presence or absence of death were observed once a day until the administration day before administration and 6 hours after administration (30 minutes after administration, 2, 4 and 6 hours after administration), and during the observation period from the day after administration; Weighing: Measurement was made on the administration day and at 1, 3, 7, 10 and 14 days after administration. At the end of the observation period, necropsy was done after exsanguination of the abdominal aorta from the abdominal aorta under ether anesthesia and then necropsied. For body weight, average values and standard deviations were calculated for each group. Significant difference test was performed using Dunnett's multiple comparison tests between control group and each administration group. No mortality was observed in both sexes. In the observation of the general condition, a decline in locomotor activity was observed in 2 to 6 hours after administration in both sexes in the 2000 mg/kg group. Besides, diarrhea was observed in each group including females of the control group, but it was considered to be based on corn oil used as a medium. In the 500 mg/kg group, low body weight was observed on both the males and females one day after administration. In the 1000 mg/kg group, low body weight was observed in both sexes on days 1 and 3 after administration. In the 2000 mg/kg group, low body weight was observed on males in 1 to 10 days after administration and in females on 1 and 3 days after administration. There was no abnormality in both sexes. Therefore, the LD50 value was considered to be >2000 mg/kg bw, when groups of 5 male and 5 female Sprague-Dawley [Crj: CD (SD) IGS, (SPF)] rats were treated with 1,2-di(ethenyl)benzene via oral gavage route.