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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral: The LD50 (oral, gavage) in male/female rats was determined >5000 mg/kg bw. The substance is not classifiable according to CLP criteria.

Dermal: The LD50 (dermal, occlusive) in male/female rats was determined >2000 mg/kg bw. The substance is not classifiable according to CLP criteria.

Inhalation: 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:
04 - 18 Jul 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
EEC Directive 79/831 4.1.1
GLP compliance:
yes
Test type:
acute toxic class 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:
The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin). The animal room was air conditioned: temperature 22±3° C, relative humidity 55+/-15%, 12 hours light/day, approximately 15 air changes/h.

Diet: rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.

Initial body weight: 168 - 201 g
Initial age: 7 - 8 weeks
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
20 mL/kg bw applied (one single dose)

Pretreatment: the animals were allocated to the different dose groups by random selection. Prior to dosing, the animals were fasted overnight.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily, once on weekend days (symptoms); days 1, 7, 14, death (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Preliminary study:
N/A
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred
Clinical signs:
other: Dyspnoea, exophthalmus, ruffled fur and curved body position being common symptoms in acute tests were seen in both sexes. In addition, the males showed transient sedation and diarrhea.
Gross pathology:
No effect in both sexes
Other findings:
None
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) in male/female rats was determined >5000 mg/kg bw. The substance is not classifiable according to CLP criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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:
05 - 19 Jul 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
EEC Directive 79/831 4.1.3
GLP compliance:
yes
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:
The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin). The animal room was air conditioned: temperature 22±3° C, relative humidity 55+/-15%, 12 hours light/day, approximately 15 air changes/h.

Diet: rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.

Initial body weight: 194 - 295 g
Initial age: 7 - 8 weeks
Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
The required amount of the test substance was evenly dispersed on the skin.It was covered with a gauze lined occlusive dressing, which was fastened around the trunk with an adhesive elastic bandage. After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the reaction of the skin was appraised repeatedly.
Duration of exposure:
14 days
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily, once on weekend days (symptoms); days 1, 7, 14, death (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Preliminary study:
N/A
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred
Clinical signs:
other: Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, ventral body position was observed during the administration period. A transient local erythema was noted on the site of administrat
Gross pathology:
Male: enlarged liver
Female: none
Other findings:
None
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (dermal, occlusive) in male/female rats was determined >2000 mg/kg bw. The substance is not classifiable according to CLP criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

The substance did not cause any lethal effects in male/female rats when applied orally (5000 mg/kg bw) and dermally (2000 mg/kg bw). The substance does not fulfil the classification criteria according to Regulation (EC) 1272/2008.