Ethyl 2-methyl-1,3-dioxolane-2-acetate

Endpoint summary

Description of key information

ORAL

LD50 > 5.0 g/kg, rat, Moreno (1980 & 1978)

DERMAL

LD50 > 5.0 g/kg, rabbit, Moreno (1980 & 1978)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

No guideline, or experimental methodology, stipulated in report summary.

GLP compliance:

no

Remarks:

study pre-dates GLP

Test type:

other: no data

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No further information on test animals and environmental conditions is reported.

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

no data

Doses:

5.0 g/kg

No. of animals per sex per dose:

10 animals were used in the study.

Control animals:

not specified

Details on study design:

no data

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg

Based on:

not specified

Mortality:

None of the 10 animals tested died during the study.

Clinical signs:

other: Toxic signs at 5.0 g/kg included lethargy, ataxia, ptosis, diarrhea, piloerection, chromorhinorrhea and chromodacryorrhea.

Gross pathology:

Nine of the survivors appeared normal at necropsy. One animal had dark areas in the lungs and a yellow exudate in the nose/mouth.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test material was reported to be in excess of 5.0 g/kg.

Executive summary:

The acute oral toxicity of the test material was investigated with 10 rats in a limit test. The animals were orally administered test material at 5.0 g/kg.

None of the 10 animals tested died during the study. Toxic signs at 5.0 g/kg included lethargy, ataxia, ptosis, diarrhea, piloerection, chromorhinorrhea and chromodacryorrhea. At necropsy, nine of the animals appeared normal. One animal had dark areas in the lungs and a yellow exudate in the nose/mouth.

The acute oral LD50 of the test material was reported to be in excess of 5.0 g/kg.

The summary report contains extremely limited detail on experimental conditions.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

No guideline, or experimental methodology, stipulated in the report summary.

GLP compliance:

no

Remarks:

study pre-dates GLP

Test type:

other: no data

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No further information on test animals and environmental conditions is reported.

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

no data

Doses:

5.0 g/kg

No. of animals per sex per dose:

10 animals were used in the study.

Control animals:

not specified

Details on study design:

no data

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg

Based on:

not specified

Mortality:

None of the 10 animals tested died during the study.

Clinical signs:

other: There were no principal toxic signs.

Gross pathology:

All of the survivors appeared normal at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test material was reported to be in excess of 5.0 g/kg.

Executive summary:

The acute oral toxicity of the test material was investigated with 10 rats in a limit test. The animals were orally administered test material at 5.0 g/kg. None of the 10 animals tested died during the study. There were no principal toxic signs and all of the survivors appeared normal at necropsy. The acute oral LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.

The summary report contains extremely limited detail on experimental conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Two study summaries are available. However, neither provide detail on experimental conditions; it is therefore not possible to assess the reliability of the presented results. Both studies were assigned a reliability score of 4 according to the criteria of Klimisch. Since both studies provided that same result, the overall reliability is improved when the studies are considered in a weight of evidence approach. Together, the studies are deemed adequate for assessment as an accurate reflection of the substance.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

No guideline or experimental methodology stipulated in the report summary.

GLP compliance:

yes

Remarks:

study pre-dates GLP

Test type:

other: no data

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No further information on test animals and environmental conditions is reported.

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

no data

Duration of exposure:

no data

Doses:

5.0 g/kg

No. of animals per sex per dose:

10 animals were used in the study.

Control animals:

not specified

Details on study design:

no data

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg

Based on:

not specified

Mortality:

None of the 10 animals tested died during the study.

Clinical signs:

other: Toxic signs included lethargy, diarrhea, ptosis, yellow exudate at nose with white nasal discharge, mucus in stool, bloated abdomen and sore under lower lip.

Gross pathology:

Eight survivors appeared normal at necropsy. Two had bright orange lungs, one had a mottled kidney, and one had a pale kidney.

Other findings:

Skin irritation was observed on day 1.
Slight redness was observed in eight animals and moderate redness was observed in one animal; the other treated animal was observed to have no redness.
Slight edema was noted on 4 animals, moderate edema on 2 animals and no edema on the remaining 4 animals.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of the test material was reported to be in excess of 5.0 g/kg.

Executive summary:

The acute dermal toxicity of the test material was investigated with 10 rabbits; each was dermally administered 5.0 g/kg test material, in a limit test. None of the animals tested died during the study. Toxic signs included lethargy, diarrhea, ptosis, yellow exudate at nose with white nasal discharge, mucus in stool, bloated abdomen and sore under lower lip. Slight to moderate redness and edema was noted in some animals during the observations for skin irritatation on day 1. At gross necropsy eight survivors appeared normal, two had bright orange lungs, one had a mottled kidney, and one had a pale kidney.

The acute dermal LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

No guideline or experimental methodology stipulated in the report summary.

GLP compliance:

yes

Remarks:

study pre-dates GLP

Test type:

other: no data

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No further information on test animals and environmental conditions is reported.

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

no data

Duration of exposure:

no data

Doses:

5.0 g/kg

No. of animals per sex per dose:

10 animals were used in the study.

Control animals:

not specified

Details on study design:

no data

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg

Based on:

not specified

Mortality:

None of the 10 animals tested died during the study.

Clinical signs:

other: There were no principal toxic signs.

Gross pathology:

At gross pathology one survivor had a soiled anogenital area and caecum.

Other findings:

Skin irritation on day 1 was observed to be absent to slight.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of the test material was reported to be in excess of 5.0 g/kg.

Executive summary:

The acute dermal toxicity of the test material was investigated with 10 rabbits; each was dermally administered 5.0 g/kg test material, in a limit test. None of the animals died during the study. There were no principal toxic signs and nine of the survivors appeared normal at gross necropsy. At gross necropsy one survivor had a soiled anogenital area and caecum. Skin irritation on day 1 was observed to be absent to slight.

The acute dermal LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Two study summaries are available. However, neither provide detail on experimental conditions; it is therefore not possible to assess the reliability of the presented results. Both studies were assigned a reliability score of 4 according to the criteria of Klimisch. Since both studies provided that same result, the overall reliability is improved when the studies are considered in a weight of evidence approach. Together, the studies are deemed adequate for assessment as an accurate reflection of the substance.

Additional information

Oral

Summaries are available on two acute oral toxicity studies which were conducted with rats. Each was performed as a limit test whereby 10 rats were orally administered with 5.0 g/kg of test material.

In the first study (Moreno, 1980), none of the 10 animals tested died during the study. There were no principal toxic signs and all of the survivors appeared normal at necropsy. The acute oral LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.

In the second study (Moreno, 1978), none of the 10 animals tested died during the study. Toxic signs at 5.0 g/kg included lethargy, ataxia, ptosis, diarrhea, piloerection, chromorhinorrhea and chromodacryorrhea. At necropsy, nine of the animals appeared normal. One animal had dark areas in the lungs and a yellow exudate in the nose/mouth. Again, the acute oral LD50 of the test material was reported to be in excess of 5.0 g/kg.

Both summary reports contain extremely limited detail on experimental conditions.

Together, the studies are deemed adequate for assessment as an accurate reflection of the substance.

The available data are considered to be complete and the result determined, oral LD50 ≥ 5000 mg/kg, was taken forward for risk assessment.

Dermal

Summaries are available on two acute dermal toxicity studies which were conducted with rabbits. Each was performed as a limit test whereby 10 rabbits each received dermal applications of test material at a concentration of 5.0 g/kg.

In the first study (Moreno, 1980), none of the animals tested died during the study. There were no principal toxic signs and nine of the survivors appeared normal at gross necropsy. At gross necropsy one survivor had a soiled anogenital area and caecum. Skin irritation on day 1 was observed to be absent to slight. The acute dermal LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.

In the second study (Moreno, 1978), none of the animals tested died during the study. Toxic signs included lethargy, diarrhea, ptosis, yellow exudate at nose with white nasal discharge, mucus in stool, bloated abdomen and sore under lower lip. Slight to moderate redness and edema was noted in some animals during the observations for skin irritation on day 1. At gross necropsy eight survivors appeared normal, two had bright orange lungs, one had a mottled kidney, and one had a pale kidney. Again, the acute dermal LD50 of the test material was reported to be in excess of 5.0 g/kg.

Both summary reports contain extremely limited detail on experimental conditions.

Together, the studies are deemed adequate for assessment as an accurate reflection of the substance.

The available data are considered to be complete and the result determined, dermal LD50 ≥ 5000 mg/kg, was taken forward for risk assessment.

Justification for selection of acute toxicity – oral endpoint

No single study is selected as the key study. The two available studies were considered together in a weight of evidence approach.

Justification for selection of acute toxicity – dermal endpoint

No single study is selected as the key study. The two available studies were considered together in a weight of evidence approach.

Justification for classification or non-classification

Oral

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification as no signs of toxicity were noted during the course of the studies.

Dermal

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification as no signs of toxicity were noted during the course of the studies.