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Description of key information

The acute oral toxicity of Tarwood was investigated in a study in rats that was performed in accordance with the requirements of the following guidelines and test methods:
- OECD GUIDELINES FOR TESTING OF CHEMICALS 423 (17th December 2001)
- Council Regulation (EC) No 440/2008 (30 May 2008),
- Regulation (EC) No. 1272/2008

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:
21.01.2014 - 06.02.2014
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
other: Crl:(WI)BR rats
Sex:
female
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
2000 mg/kg bw
Control animals:
not specified
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

see study report for further information

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The method used, was not intended for the precise calculation of a precise LD50 value. The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423.
Executive summary:

An acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, therefore treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 (presented in Appendix VII) was met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

An acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, therefore treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 (presented in Appendix VII) was met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.

Lethality, Clinical symptoms and Body weight:

No lethality was noted at single oral dose of 2000 mg/kg bw. No clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal. The body weight development was undisturbed in all animals.

Gross pathology:

All animals survived until the scheduled autopsy on Day 15. All organs of all experimental animals proved to be free of treatment related gross pathological changes.

Evaluation:

The method used is not intended to allow the calculation of a precise LD50 value. The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423 as below:

Dose (mg/kg bw)

Mortality (dead/treated)

LD50(mg/kg bw)

GHS

category

2000

0/6

above 2000

5



Justification for selection of acute toxicity – inhalation endpoint
Inhalation of Tarwood is unlikely. Tarwood is a viscous medium.

Justification for classification or non-classification

Following OECD GUIDELINE FOR TESTING OF CHEMICALS No 423 Annex 2d no mortality was observed.

No death occurred at 2000 mg/kg bw single oral dose of Tar wood. All female rats in step 1 and step 2 survived.