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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
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
other: read-across target
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1), see attached justification.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
< 2 000 mg/kg bw
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
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

Constituent 1
Reference substance name:
Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1]: Octyltin tris(2-EHMA) [CAS No. 27107-89-7] (90:10% mixture)
IUPAC Name:
Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1]: Octyltin tris(2-EHMA) [CAS No. 27107-89-7] (90:10% mixture)
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 or test system 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: groups of rats were fasted overnight and administered a single oral dose of the test material
- Housing: in groups of 5
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- 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:
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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
< 2 000 mg/kg bw
Key result
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 test material-related gross organ changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
The acute oral LD50 of the test material was determined to be 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guideline OECD 410, under GLP conditions.

During the study, two doses were tested (single dose of 1000 and 2000 mg/kg bw/d) with a 14 -day observation period.

Animals in both dose groups exhibited clinical signs of toxicity and effects on mortality were observed.

Under the conditions of the study the acute oral LD50 of the test material was determined to be 2000 mg/kg bw.