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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

Referenceopen allclose all

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 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:
no data
Body weight:
The average bodyweight in most of the rats ranged around 175 g.
Gross pathology:
no data
Other findings:
no data

The doses were not indicated in mg/kg bw but only in mg. The LD50 was calculated in accordance with weight of animals.

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 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:
Toxic signs were lethargy and loss of righting reflex.
Body weight:
no data
Gross pathology:
no data

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.

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.

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.