Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Remarks:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: older study; not conducted in accordance with current GLP guidelines
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
guinea pig
Strain:
Hartley
Type of coverage:
occlusive
Preparation of test site:
other: depilated using barium sulfide/talc/starch/commercial laundry detergent
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
1, 5, 10, 20 mL/kg
Number of animals:
six
Details on study design:
The abdomens of six guinea pigs were depilated. Following depilation, the animals were exposed dermally to doses of 1 (one animal), 5 (one animal), 1 0( one animal), or 20(three animals) mL/kg for 24 hours via gauze pads to which the appropriate amount of test substance had been applied. The pads were held in place by impervious rubber dental dam material wrapped around the torso of the animal and secured with rubber cement. The skin was evaluated immediately after removal of the wrapping material and one and two weeks later
Irritation parameter:
overall irritation score
Time point:
other: 14 days
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
At initiation of the study, the guinea pigs weighed between 475 and 593grams. Immediately after the animals were unwrapped, clinical signs of irritation on all six animals included moderate to severe erythema, moderate to gross edema and some evidence of necrosis. At one week, thin, dried eschars covered the entire area of the application site for all six animals. By termination of the 14-day study, the application sites had small, scattered light eschars, desquamation, alopecia, and light scarring. The severity of the signs was not related to dose. All animals gained weight during the study.
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance was rated a moderate irritant under the conditions of this study
Executive summary:

A screening study was conducted in six guinea pigs to estimate dermal irritation, dermal toxicity, and dermal absorption of the test substance. In this study the abdomens of six guinea pigs were depilated using a depilatory containing barium sulfide, talc, starch, and a commercial laundry detergent, wetted to make a thin paste. Following depilation, the animals were exposed dermally to doses of 1 (one animal), 5 (one animal), 1 0( one animal), or 20(three animals) mL/kg for 24 hours via gauze pads to which the appropriate amount of test substance had been applied. The pads were held in place by impervious rubber dental dam material wrapped around the torso of the animal and secured with rubber cement. At initiation of the study, the guinea pigs weighed between 475 and 593 grams. The skin was evaluated immediately after removal of the wrapping material and one and two weeks later. Immediately after the animals were unwrapped, clinical signs of irritation on all six animals included moderate to severe erythema, moderate to gross edema and some evidence of necrosis. At one week, thin, dried eschars covered the entire area of the application site for all six animals. By termination of the 14-day study, the application sites had small, scattered light eschars, desquamation, alopecia, and light scarring. The severity of the signs was not related to dose. All animals gained weight during the study. The test substance was rated a moderate irritant under the conditions of this study,

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: older study; not conducted in accordance with current GLP guidelines
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
3
Details on study design:
Eye irritation studies in the Kodak laboratory were conducted using a method similar to that described in the current OECD Guideline. However, the test material was administered to six, rather than three, rabbit eyes. Three of the eyes were subsequently washed, so the effect of washing on the subsequent development of irritant responses could be evaluated. The effect of washing is not evaluated in current Guideline studies.
Irritation parameter:
overall irritation score
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Irritation, limited to erythema of the adnexa, resolved after one hour. No adnexal or corneal staining was observed. Immediate washing was beneficial.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based upon the findings of this study, p-diisopropylbenzene is slightly irritating to the eyes of rabbits.
Executive summary:

A 0.1 mL aliquot of p-diisopropylbenzene was instilled into both eyes of 3 rabbits; in one eye of each rabbit, the material was immediately rinsed with water, while in the other eye, the material remained without washing. Immediately after instillation, slight erythema was observed in 3 of 3 rabbits that was limited to the adnexa, and washing was palliative. At one hour after instillation, all signs of irritation had resolved in all rabbits.

Additional information

Justification for classification or non-classification