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Administrative data

Description of key information

2,5-Di-t-pentylhydroquinone was tested in albino rabbits for eye and skin irritation. The studies were not performed under GLP conditions or according to the current guidelines. The substance was found to be not irritating to skin and not or slightly irritating to rabbit eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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:
Rabbits were administered 0.5 gram Santovar A powder and were observed for 7 days.

GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 gram
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4, 24, 48, 72, 168 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
non-irritating
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: FHSA
Conclusions:
A study in 6 rabbits suggested that Santovar A was not irritanting for the skin. The study was not performed according to the general guidelines for acute skin irritation/corrosion 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 (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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:
Rabbits 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
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg, finely ground powder
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72, 120, 168 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72, 120, 168 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1
Score:
7.3
Max. score:
8
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24
Score:
6.3
Max. score:
8
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48, 72, 120, 168 hours
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: FHSA
Conclusions:
A study in 6 rabbits suggested that Santovar was slightly to not irritanting for the eye; reversibel (within 48 hours) erythema was described. The study was not performed according to the general guidelines for acute eye irritation/corrosion 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 (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The data of one dermal irritation/corrosion study in albino rabbits does not meet the requirements of the current guidelines, but suggested that 2,5-Di-t-pentylhydroquinone was not irritating for rabbit skin.

The data of one eye irritation/corrosion study in albino rabbits does not meet the requirements of the current guidelines, but suggested that 2,5 -Di-t-pentylhydroquinone was not to slightly irritating for rabbit eyes.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

According to the results of the skin and eye irritation studies, the substance does not need to be classified according to Directive 67/548/EC (DSD) and the CLP Regulation.