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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
Study period:
1 November 1994 - 4 November 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name: Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues
Physical state: liquid
Appearance: brown liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): AMINE C-8
- Substance type: dark brown slightly viscous liquid with crystalline sediment
- Physical state: liquid
- Analytical purity: no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: responsibility of the sponsor
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.23-2.29 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20 °C
- Humidity (%): 58-65%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1 November 1994 To: 4 November 1994

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable
Duration of treatment / exposure:
patches were removed after exposure periods of 3 min, 1 h and 4 h.
Observation period:
One hour after removal of the patches, and 24, 48 and 72 h.
Number of animals:
3 animals, with 3 test sites each
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: gauze patches secured with strips of surgical adhesive tape and wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with cotton wool soaked in distilled water
- Time after start of exposure: 3 min, 1 hour and 4 hour

SCORING SYSTEM: Draize (1977) Primary Irritation Index.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Classification: mild irritant
Remarks:
4 hours exposure
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: after 1 hour exposure
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: after 3 minutes exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: after 3 minutes, 1 hour and 4 hours of exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: after 4 hours of exposure
Irritant / corrosive response data:
After 3 min and 1 hour exposure: no erythema/eschar formation and no oedema formation.
After 4 hours exposure: very slight erythema in all three animals and very slight oedema in two animals, but fully reversible within 24-48 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material does not need to be classified as a skin irritant according to the CLP Regulation.