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Description of key information

The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight. The study was performed according to the OECD Guideline for Testing of Chemicals No. 401. No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with 2000 mg/kg of the test item. On female rat showed inhibition of body weight development. The body weight development of the other rats was inconspicuous during the study. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50value is higher than 2000 mg/kg after single oral administration in male/female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

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Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Mar 12 - May 15, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 401.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: F. Winkelmann, Borchen, Germany- Age at study initiation: 5 to 8 weeks - Weight at study initiation: 172 (158 - 186) g - Fasting period before study: 17 hours before until up to 4 hours after treatment- Housing: separately in type III Makrolon cages - Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 5 days ENVIRONMENTAL CONDITIONS- Temperature (°C): 20 to 21 °C - Humidity (%): 54 to 68 %- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regimeIN-LIFE DATES: From: day 1 To: day 15
Route of administration:
oral: gavage
Vehicle:
other: Methocel K4M Premium solution
Details on oral exposure:
VEHICLE- Concentration in vehicle: 100 g/L- Amount of vehicle (if gavage): 20 mL/kg- Justification for choice of vehicle: excellent vehicle performance in long range historical dataMAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations: for at least 6 hours after administration and then daily up to end of study- Frequency of weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Standard statistical methods have been applied for data processing.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All rats survived the observation period.
Clinical signs:
No signs of toxicity were seen in the 3 male and 3 female rats after treatment with 2000 mg/kg.
Body weight:
On female rat showed inhibition of body weight development. The body weight development of the other rats was inconspicuous during the study.
Gross pathology:
The gross pathological examination revealed no organ alterations.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 401.

Justification for selection of acute toxicity – dermal endpoint
On 15 July 2014 the Competent Authorities for REACH and CLP (Caracal) have agreed that substances that are not toxic in acute oral tests need no longer be tested for acute dermal toxicity. Caracal agreed on proposals to amend REACH Annex VIII (point 8.5.3) so that substances that have not shown oral acute toxicity up to a limit dose of 2000mg/kg bodyweight would not also require dermal data. The test material does not provide evidence for acute oral toxicity. The LD50 exceeds 2000 mg/kg bw. Therefore no further testing for dermal toxicity is justified.

Justification for classification or non-classification

In line with the results of the studies, a classification for acute toxicity is not warranted according to CLP.