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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting but otherwise adequate for assessment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
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
occlusive dressing used
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
CAS 68516-20-1
IUPAC Name:
CAS 68516-20-1
Constituent 2
Reference substance name:
E000144700
IUPAC Name:
E000144700
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 or test system 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.