2,2-dimethylthiazolidine

Endpoint summary

Description of key information

Acute oral toxicity, female/male mice, oral gavage, doses: 0, 480, 595, 738, 915, 1135, 1407, 1745 and 2164 mg/kg bw; Japanese Report and translated summary are available.

 

LD50 703.59 mg/kg bw in female mice and 798.97 mg/kg bw in male mice;

 

Mortality was observed from 30 minutes after the administration until two days afterwards. For males, mortality occured in the 595 mg/kg and higher dose groups; at doses ≥ 1135 mg/kg all males died. For females, mortality occured in the 595 mg/kg and higher dose groups; at doses ≥ 915 mg/kg, all females died.

 

Acute dermal toxicity: no study available

Acute inhalation toxicity: no study available

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-20-01 to 1987-07-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: translation of core data from a japanese study report, Japanese report available as well

Principles of method if other than guideline:

- Principle of test: 2,2-dimethylthiazolidine (DMT) was administered forcibly to male and female mice and the acute toxicity was observed.
- Parameters analysed / observed: general condition, body weight, mortality

GLP compliance:

not specified

Remarks:

within translation

Test type:

standard acute method

Limit test:

no

Species:

mouse

Sex:

male/female

Route of administration:

other: oral (administered forcibly)

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

Doses:

0, 480, 595, 738, 915, 1135, 1407, 1745 and 2164 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not given
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,histopathology

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

703.59 mg/kg bw

Based on:

test mat.

95% CL:

> 639.95 - < 772.74

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

798.97 mg/kg bw

Based on:

test mat.

95% CL:

> 723.12 - < 883.4

Mortality:

The deaths were observed from 30 minutes after the administration until two days afterwards.
In the case of the males, death was observed in the 595 mg/kg and higher administration groups; moreover in the 1135 mg/kg and higher administration groups, all the animals died.
In the case of the females, death was observed in the 595 mg/kg and higher administration groups; moreover in the 915 mg/kg and higher administration groups, all the animals died.

Clinical signs:

In terms of the general condition, sleepiness, walking on tiptoe, gait ataxia, "Kussmaul" respiration, half-closed eyes, mydriasis, lacrimation, tremor, clonic convulsions, nosebleed, etc. were observed from immediately after the administration.
No changes were observed from four days after the administration onwards.

Body weight:

595 mg/kg and higher dose groups: suppression or a tendency to suppression was seen in the body weights at day 7 and day 14 and also in the body weight gain over the period of days 0-14

Gross pathology:

- Animals found dead: dark reddening of lungs, black spots on the liver, red/reddish spots on the gastric mucosa, reddening/reddish-blackening of the small intestine-
- Terminal necropsy: kidney discoloration (grayish brown) was observed in many males.

Other findings:

- Histopathology:
- Animals found dead: congestion of pulmonary blood
- Terminal necropsy: hepatic scar formation

Both were only observed in a small number of cases.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The oral LD50 of 2,2-dimethylthiazolidine was 703.59 mg/kg bw in female mice and 798.97 mg/kg bw in male mice.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

703.59 mg/kg bw

Quality of whole database:

The study is regarded sufficient for classification and labelling although only a translated summary was available. The original japanese study report provides additional information in tabular form.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on relevant and adequate data, the test substance has to be classified according to the CLP Regulation (EC) No 1272/2008 with respect to acute oral toxicity, Category 4 and labelled with H302: Harmful if swallowed.