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Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan 20, 1986 - Feb 25, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FIFRA (US EPA)
Qualifier:
according to guideline
Guideline:
other: TSCA (US EPA)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Diisopropylbiphenyl and triisopropylbiphenyl
EC Number:
915-589-8
Molecular formula:
not applicable for UVCB substance
IUPAC Name:
Diisopropylbiphenyl and triisopropylbiphenyl
Details on test material:
- Name of test material (as cited in study report): Diisopropyl biphenyl, isomeric mixture (acronym used: DIPB or di-IPB/tri-IPB)
- Substance type: organic
- Density: 0.9669 g/ml
- Physical state: clear liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Isomers composition: no data
- Lot/batch No.: NBP-3184823
- Expiration date of the lot/batch: no data
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Species: New Zealand White, albino rabbits
- Source: Hazleton-Dutchland, Inc.; Denver, Pennsylvania
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel cages
- Diet: Lab Rabbit Chow HF, ad libitum:
- Water: ad libitum
- Acclimation period: 22 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 16°C - 21°C (60 - 70°F)
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
other: see below
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml (undiluted) per site


Duration of treatment / exposure:
Single 4- or 24-hour exposure
Observation period:
3-14 d
Number of animals:
6 (2 males, 4 females)
Details on study design:
TEST SITE
The test material was applied to four intact sites on each animal.
Two sites were semi-occluded, two sites were occluded for 24 h.
Exposure period: Two sites for 4 h, two sites for 24 h

ADMINISTRATION OF TEST MATERIAL
- 4-h exposure, semi-occlusive
- 24-h exposure, occlusive

SCORING SYSTEM:
All sites were evaluated for erythrema, edema and other evidence of dermal irritation according to the DRAIZE scoring system.
Adjacent areas of untreated skin were used for comparison.
Special notations were made to describe evidence of epidemal and subepidermal destruction.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
(24 h exposure)
Basis:
mean
Time point:
other: 24 - 72 h
Score:
4.3
Max. score:
8
Reversibility:
fully reversible
Remarks:
10 d
Irritation parameter:
erythema score
Basis:
animal: 8876
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
erythema score
Basis:
animal: 8882
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
erythema score
Basis:
animal: 8897
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
erythema score
Basis:
animal: 8904
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
erythema score
Basis:
animal: 8906
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
erythema score
Basis:
animal: 8907
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
edema score
Basis:
animal: 8876
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
edema score
Basis:
animal: 8882
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
edema score
Basis:
animal: 8897
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
edema score
Basis:
animal: 8904
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
edema score
Basis:
animal: 8906
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
edema score
Basis:
animal: 8907
Time point:
24/48/72 h
Score:
2.2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
other: desquamation
Basis:
animal: 8882
Time point:
7 d
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure, two treated sites (left and right forelimb)
Irritation parameter:
other: desquamation
Basis:
animal: 8897
Time point:
7 d
Reversibility:
not fully reversible within: 10 day
Remarks on result:
other: 4 hour exposure, two treated sites (left and right forelimb)
Irritation parameter:
other: desquamation
Basis:
animal: 8904
Time point:
7 d
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
Irritation parameter:
other: desquamation
Basis:
animal: 8906
Time point:
7 d
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, two treated sites (left and right forelimb)
Irritation parameter:
other: desquamation
Basis:
animal: 8907
Time point:
7 d
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, two treated sites (left and right forelimb)
Irritation parameter:
other: desquamation
Basis:
animal: 8876
Time point:
7 d
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: 4 hour exposure, two treated sites (left and right forelimb)
Irritation parameter:
other: superficial necrosis
Basis:
animal: 8897
Time point:
7 d
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, two treated sites (left and right forelimb)
Irritation parameter:
other: superficial necrosis
Basis:
animal: 8906
Time point:
7 d
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure, two treated sites (left and right forelimb)
Irritant / corrosive response data:
Irritation was generally mild to moderate (for both 4-h exposure under semi-occlusive and 24-h exposure under occlusive covering). In isolated cases after 4h exposure, scores were graded with 3 to 4 from 24 to 48 h. 1/6 animal exhibited an erythema scored with 4 until day 7, but completely cleared by day 10.
Although 3 of 6 animals had superficial (epidermal) tissue damage at one or more sites, no subepidermal tissue damage was seen.
Desquamation and/or superficial necrosis were not reversible in 5 of 6 animals within 10 or 14 days.
Other effects:
see above

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria met, classified as Skin Irrit. 2 according to Regulation (EC) No 1272/2008
Conclusions:
A reliable study, conducted in accordance with FIFRA and TSCA guidelines, found the test material to be irritating to the skin of rabbits. Although the cut-off criteria of ≥ 2.3 for edema and erythema was only reached for one rabbit, desquamation and/or superficial necrosis were noted in all 6 animals and desquamation was not reversible within the observation period (10 to 14 days) in 5 animals.