Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity of 2,5-Di-t-pentylhydroquinone was tested in one study with male and female rats. In addition, acute dermal toxicity of 2,5-Di-t-pentylhydroquinone was tested in one study with male and female rabbits.

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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not performed under GLP conditions, used methods and results are preliminary documented.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were administered 1260, 1580, 2000, 2510, 3160 mg/kg bw Santovar A in corn oil as single oral dose and were observed for 14 days.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
no information provided
Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
1260, 1580, 2000, 2510, 3160 mg/kg bw Santovar A
No. of animals per sex per dose:
3 or 2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 900 mg/kg bw
95% CL:
> 1 800 - < 2 000
Mortality:
Yes
Clinical signs:
Reduced appetite and activity, increasing weakness, collapse, and death.
Body weight:
Only inital weights reported.
Gross pathology:
Hemorrahagic areas of the lungs, slight liver hyperemia, and acute gastrointestinal inflammation.
Other findings:
none
Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
A study in rats suggested that Santovar was slightly toxic, an oral LD50 of 1900 mg/kg bw was reported. The study was not performed according to the general guidelines for acute oral toxicity under GLP conditions and was very poorly documented. Therefore, the information may be considered reliable with major restrictions.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 900 mg/kg bw

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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not performed under GLP conditions, used methods and results are preliminary documented.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were exposed to 2000, 3160, 5010, 7940 mg/kg bw Santovar A in corn oil during 24 hours and were observed for 14 days.

GLP compliance:
not specified
Test type:
standard acute method
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
not specified
Vehicle:
corn oil
Duration of exposure:
24 hours
Doses:
2000, 3160, 5010, 7940 mg/kg bw Santovar A
No. of animals per sex per dose:
1 or 2 at highest dose
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
Yes, at 5010 and 7940 mg/kg bw after 4 and 5 days, resp.
Clinical signs:
Reduced appetite and activity, increasing weakness, collapse, and death.

Body weight:
Only inital weights reported.

Gross pathology:
Lung and liver hyperemia, enlarged gall bladder, and gastrointestinal inflammation.
Other findings:
none
Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Executive summary:
A study in rabbits suggested that Santovar was slightly toxic, a dermal LD50 of > 3160 mg/kg bw was reported. The study was not performed according to the general guidelines for dermal toxicity under GLP conditions and was very poorly documented. Therefore, the information may be considered reliable with major restrictions.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 160 mg/kg bw

Additional information

The studies were not performed according to the general guidelines for acute oral/dermal toxicity testing neither performed under GLP-conditions and were documented poorly. Therefore, the data should be considered as indicative only. Upon oral administration of 2,5-Di-t-pentylhydroquinone to rats an LD50 of 1900 mg/kg bw is reported and upon dermal administration of 2,5-Di-t-pentylhydroquinone to rabbits an LD50 of > 3160 mg/kg bw is reported.

Justification for classification or non-classification

Based on the above mentioned results, the substance shall be classified for acute toxicity with R22 according to Dangerous Substance Directive 67/548/EC and Acute tox 4 according to CLP Regulation (EC) 1272/2008.