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Description of key information

Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1)

In the key study, the acute oral LD50 was determined to be 2000 mg/kg bw.

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:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
other: read-across target
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
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
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.
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.
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.

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
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE:MOTE 90:10) (CAS No. 15571-58-1 and CAS 27107 -89-7)

Anonymous (1992)

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.

Anonymous (1976) Read-across data (mixture DOTE: MOTE. 75:25) (CAS No 15571-58-1 and CAS 27107-89-7)

The acute oral toxicity of the test material was determined in a study which was conducted according to a method that is comparable to the standardised guideline OECD 401.

During the study, groups of 5 male and 5 female rats were fasted overnight and administered a single oral dose of the test material at dose levels of 300, 600, 1000, 1500, 3000, 6000, and 10000 mg/kg bw. Animals were observed for 14 days. Animals that died were sacrificed and necropsied. Surviving animals were sacrificed and necropsied at the end of the observation period.

Under the conditions of the study none of the rats dosed at levels up to and including 1500 mg/kg bw died. Four males and two females dosed at 3000 mg/kg bw died, five males and four females dosed at 6000 mg/kg bw died, and all animals dosed at 10000 mg/kg bw died. Signs and symptoms of toxicity at dose levels ≥ 3000 mg/kg bw included transient hypoventilation, roughening of the coat, ataxia, ventricumbency, muscular hypotonia, inhibition to pain, and piloerection. Gross changes in animals that died during the study included pulmonary oedema, gastroenteritis with dilated stomach and slight atrophied thymus and spleen. No gross changes were observed in animals that survived the study/observation period.  

Under the conditions of this study the LD50 of the test material was 3050 mg/kg bw.

Anonymous (1982) Read-across data (mixture DOTE: MOTE. 53:22) (CAS No 15571-58-1 and CAS 27107-89-7)

The acute oral toxicity of the test material was determined in a study which was conducted according to a method that is comparable to the standardised guideline OECD 401.

During the study, groups of 5 male and 5 female rats were fasted overnight and administered a single oral dose of the test material at dose levels of 1000, 2500, and 5000 mg/kg bw. Animals were observed for 14 days.  Body weights were recorded on days 1 (prior to dosing), 7, 14, and at death.  Animals that died were sacrificed and necropsied. Surviving animals were sacrificed and necropsied at the end of the observation period.

Under the conditions of the study none of the rats dosed at 1000 mg/kg bw died. At 2500 mg/kg bw 1 male and 3 females died, and at the top dose level of 5000 mg/kg bw all the animals died. Signs and symptoms of toxicity included sedation, dyspnoea, ruffled fur, diarrhea, exophthalmus, anc curved body position.

Under the conditions of the study the acute oral LD50 of the test material was determined to be 2775 mg/kg bw.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute oral toxicity.