Registration Dossier
Registration Dossier
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EC number: 205-771-9 | CAS number: 150-78-7
Endpoint summary
Administrative data
Description of key information
LD50 range by oral route: 3600 - 8500 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: No enough details. Documentation is insufficient for assessment.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
- Test type:
- other:
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species: rat
- Strain: no data
- Sex: no data
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: Average weight of animals:
- group tested at 1000 mg: 175 g
- group tested at 1250 mg: 172 g
- group tested at 1500 mg: 176 g
- group tested at 1750 mg: 130 g.
- Fasting period before study: no data
- Housing: no data
- Food consumption: no data
- Water consumption: no data
- Acclimation period: no data
Environmental conditions: no data
In-life dates: no data - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Maximum dose volume applied: 1750 mg
- Dosage preparation (if unusual): no data
- Rationale for the selection of the starting dose: no data - Doses:
- 1000; 1250; 1500; 1750 mg corresponding to 5714 mg/kg, 7267 mg/kg, 8522 mg/kg and 13461 mg/kg.
- No. of animals per sex per dose:
- for doses of 1000, 1250 and 1500 mg, 10 animals per dose.
For dose of 1750 mg, only one animal.
Sex unspecified. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- examinations performed: other: no data - Statistics:
- no data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 8 500 mg/kg bw
- Mortality:
- 2/10 died at dose of 1000 mg (5714 mg/kg), whereas, 5/10 died at dose of 1500 mg (8522 mg/kg). One rat treated at dose of 1750 mg/kg, died.
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to EU and UN GHS criterias, the substance is not classified for acute oral toxicity.
- Executive summary:
In a oral acute study, rats were exposed to 5714 mg/kg, 7267 mg/kg, 8522 mg/kg and 13461 mg/kg of the test substance. The LD50 is 8500 mg/kg. Based on this value, the substance is not classified for acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Unpublished RIFM report. No details were done on the experimental study.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species: rat
- Strain: no data
- Sex: no data
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: no data
- Food consumption: no data
- Water consumption: no data
- Acclimation period: no data
Environmental conditions: no data
In-life dates: no data - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- 2560; 3200; 4000; 5000 mg/kg
- No. of animals per sex per dose:
- 10 (sex unspecified)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- examinations performed: other: no data - Statistics:
- no data on statistical method used for calculation of LD50
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 600 mg/kg bw
- 95% CL:
- 3 130 - 4 070
- Mortality:
- 2560 mg/kg lethal, 3 deaths.
3200 mg/kg lethal, 4 deaths.
4000 mg/kg lethal, 6 deaths.
5000 mg/kg lethal, 10 deaths. - Clinical signs:
- other: Toxic signs were lethargy and loss of righting reflex.
- Gross pathology:
- no data
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- According to EU GHS criteria, the substance is considered not classified for acute oral toxicity.
According to UN GHS criteria, the substance is classified Acute. Tox. Cat. 5, H303. - Executive summary:
In an acute toxic class method study, rats were exposed to 2560, 3200, 4000 and 5000 mg/kg of 1,4 -dimethoxybenzene (PDMB). The LD50 calculated is 3600 mg/kg (95% CL: 3130 - 4070 mg/kg). Based on this result, the substance is not classified according to EU GHS criteria.
Referenceopen allclose all
The doses were not indicated in mg/kg bw but only in mg. The LD50 was calculated in accordance with weight of animals.
2560 mg/kg lethal, 3 deaths, Lethargy.
3200 mg/kg lethal, 4 deaths, Lethargy.
4000 mg/kg lethal, 6 deaths, Lethargy.
5000 mg/kg lethal, 10 deaths. Toxic signs were lethargy and loss of righting reflex.
3600 mg/kg calculated LD50, 95% limits=3130-4070 mg/kg.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Oral:
Two studies, one with reliability 3 and one with reliability 4 according to Klimisch were available. As the LD50 in rats was in the range from 3600 to 8500 mg/kg, no key study was chosen and a "Weight of Evidence" approach was applied.
Dermal:
Only one unpublished study from RIFM was available. As it was with reliability 4, no purpose flag was chosen. The result gave a LD50 above 5000 mg/kg.
Justification for classification or non-classification
Based on two studies used in a WOE approach, the LD50 in rats was in the range from 3600 to 8500 mg/kg. Based on this range, the substance is not classified for acute oral toxicity according to EU GHS criteria and classified Acute. Tox. Cat. 5, H303 according to UN GHS criteria.
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