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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:
other: Guideline study (OECD 401) with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
2 doses were used but one dose only with males and females
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1]: Octyltin tris(2-EHMA) [CAS No. 27107-89-7] (90:10% mixture)

Test animals

Species:
rat
Strain:
other: Tif:RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 190-215 g
- Fasting period before study: no (but before administration)
- Housing: in groups of 5
- Diet (e.g. ad libitum): not precised, ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% (w/v) CMC in 0.1% (w/v) polysorbate-80 (aq.)
Details on oral exposure:
Groups of rats were fasted overnight and administered a single oral dose of the test substance (dose volume = 10 ml/kg bw).
Doses:
1000 and 2000 mg/kg bw
No. of animals per sex per dose:
1000 mg/kg bw: 5 males
2000 mg/kg bw: 5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: once or twice daily for clinical signs of toxicity and mortality
- Frequency of weighing: on days 1 (prior to dosing), 7, 14, or at death
- Necropsy of survivors performed: yes. Animals that died were sacrificed and necropsied. Surviving animals were sacrificed and necropsied at the end of the exposure period.
Statistics:
Mortality data were evaluated and the LD50 (with lower 95% confidence limit) was calculated by the logit model.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
< 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Mortality (number dead/total number exposed), by sex and concentration tested:
1000 mg/kg bw: 0/5 (males only)
2000 mg/kg bw: 1/5 male (died day 9), 4/5 females (died days 9, 10, 12, 13)
Clinical signs:
Animals in both dose groups exhibited clinical signs of toxicity that included slight to moderate piloerection, dyspnea, hunched posture, and reduced locomotor activity. A single male in the 2000 mg/kg bw dose group exhibited signs of ataxia and cyanosis; all 5 females in that group also showed signs of ataxia. Surviving animals recovered within 6-13 days.
Body weight:
no data
Gross pathology:
No substance-related gross organ changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation EC No 1272/2008 (CLP)
Conclusions:
The acute oral toxicity rat LD50 was determined to be 2000 mg/kg bw for DOT(2-EHMA).
Executive summary:

An acute oral toxicity to rat study (OECD 401) was carried out with a mixture of DOT (2 -EHMA) and MOT(2 -EHMA) (90:10%) . Two doses were tested (single dose of 1000 and 2000 mg/kg bw/d) with a 14 -days observation period. Animals in both dose groups exhibited clinical signs of toxicity and effects on mortality were observed. The LD50 was lower for female rats, the overall LD50 was 2000 mg/kg bw .