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Description of key information

LD50 (rat, oral) is greater than 5000 mg/kg bw.
LD50 (rat, dermal) is greater than 2000 mg/kg bw.

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:
July 25- August 29, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline test
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Rat, Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 178 - 202 g
- Fasting period before study: overnight
- Housing: They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bed-ding.
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) was provided ad libitum.
- Water (e.g. ad libitum): water was provided ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 55 ±15%
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Route of administration:
oral: gavage
Vehicle:
other: 01. arachidis Ph. H. VI Siegfried AG
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg body weight
- Rationale for the selection of the starting dose: 5000 mg/kg bw
Doses:
one single dose of 5000 mg/kg bw
No. of animals per sex per dose:
5 females and 5 males per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 7 and 14 day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights
Statistics:
From the body weights, the group means and their standard deviations were calculated. Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality found
Mortality:
No mortality
Clinical signs:
other: Dyspnoea, exophthalmus, ruffled fur, and curved body position and a slight diarrhoea were observed . However, the animals recovered within 13 days.
Gross pathology:
No gross organ changes were observed.
Other findings:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
According to the test results, there was no acute toxicity of test article to rat under test the applied condition.
Executive summary:

The test article was administrated to rats of both sexes by oral gavage at one single dose of 5000 mg/kg to access the acute toxicity according to OECD TG 401 (limit test). No mortality was observed. Dyspnoea, exophthalmus, ruffled fur, and curved body position and a slight diarrhoea were observed . However, the animals recovered within 13 days. No gross organ changes were observed. Therefore, the LD50 of test article is determined to be greater than 5000 mg/kg bw, which indicates that test article is unclassified according to CLP (Regulation EC No. 1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Only this study is available.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 24 - August 29, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline test
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 192 - 215 g
- Fasting period before study: overnight
- Housing: They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding.
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) was provided ad libitum.
- Water (e.g. ad libitum): water was provided ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 55 ±15%
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Type of coverage:
semiocclusive
Vehicle:
other: 0l. arachidis Ph. H. VI Siegfried AG
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg hody weight

Duration of exposure:
24 h
Doses:
single dose of 2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on working days, daily, a.m. and p.m. a.m. on weekends for mortaility; on days 1, 7, 14 and at death for body weight
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
From the body weights, the group means and their standard deviations were calculated. Where: feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
No mortailty
Clinical signs:
other: Dyspnoea, exophthalmus, ruffled fur and abnormal body positions.
Gross pathology:
No tireatment-related deviations from normal morphology detected.
Other findings:
No data
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the test condition, it can conclude that LD50 (dermal) of test article to rat is greater than 2000 mg/kg bw.
Executive summary:

The test substance was applied to the skin of rats of both sexes for 24 hrs at a dose of 2000 mg/kg to access the acute toxicity. No mortality was observed at test concentration. No deviation from normal mophology at necropsy. No tireatment-related deviations from normal morphology was detected in any animal. Dyspnoea, exophthalmus, ruffled fur and abnormal body positions were observed, but all rats had recovered within 12 days. Therefore, the LD50 of test substance was estimated to be greater than 2000 mg/kg bw, which indicates that test substance is unclassified in accordance with CLP (Regulaton EC No. 1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Only this study is available

Additional information

Oral toxicity test and dermal toxicity test of the test substance were performed according to the OECD guideline. The inhalation toxicity test is waived according to COLUMN 2 of REACH ANNEX VIII.

The test substance was administrated to rats of both sexes by oral gavage at one single dose of 5000 mg/kg to access the acute oral toxicity according to OECD TG 401. No mortality was observed. Dyspnoea, exophthalmus, ruffled fur, and curved body position and a slight diarrhoea were observed . However, the animals recovered within 13 days. No gross organ changes were observed. Therefore, the LD50 of the test article is greater than 5000 mg/kg bw.

The test substance was applied to the skin of rats of both sexes for 24 hrs at a dose of 2000 mg/kg to access the acute dermal toxicity. No mortality was observed at the test concentration. No deviation from normal morphology at necropsy. No treatment-related deviations from normal morphology were detected in any of the animals. Dyspnoea, exophthalmus, ruffled fur and abnormal body positions were observed, but all rats had recovered within 12 days. Therefore, the LD50 of the test substance was greater than 2000 mg/kg bw.

Justification for classification or non-classification

Based on the results of oral and dermal toxicity tests, the substance does not need to be classified according to CLP (Regulation (EC) No 1272/2008) or DSD (Directive 67/548/EEC) respectively. Data on inhalative toxicity are lacking.

No observations were made in the studies performed indicating the necessity to classify for specific target organ toxicity, single exposure.