Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
occlusive dressing used
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): E000144700
- Physical state: Clear, pale yellow to yellow liquid, gasoline-like naphtha odour
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Stable
- Storage condition of test material: 50-80°F

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sterling Rabbitry, Wellsville, Utah, USA.
- Age at study initiation: Young adult
- Weight at study initiation: 2.0-4.0 kg
- Housing: Individually in stainless steel, wire mesh bottom cages.
- Diet: Fresh certified Agway rabbit feed ad libitum
- Water: Fresh potable water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 61-71°F
- Humidity: 40-60%
- Air changes: At least 10 per hr
- Photoperiod: 12hrs dark / 12hrs light

IN-LIFE DATES: From: 5 February 1990 To: 8 February 1990

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other:
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area (approximately 1 square inch)
- Type of wrap if used: gauze patch taped with hypoallergenic tape and wrapped with an impervious, non-reactive rubberised material and taped in place.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.8
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: scores at all time points
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
3.2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: scores at all time points

Applicant's summary and conclusion

Interpretation of results:
other: Irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
E000144700 is irritating but not corrosive to the skin.
Executive summary:

The primary dermal irritation of E000144700 (CAS 68516-20-1) was investigated in a group of 6 albino rabbits. 0.5 mL of neat test substance was applied to approximately 1 square inch of shaved dorsal skin and retained in contact for 4 hours under an occlusive dressing. Erythema and oedema was seen in all six animals from 1 hour until 72 hours after removal of the dressing. Mean erythema and oedema scores over 24, 48 and 72 hours were greater than 2.

 

E000144700 (CAS 68516-20-1) is considered to be irritating to rabbit skin and warrants classification Category 2, H315 under GHS/CLP.