Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets scientific standards with acceptable restrictions (limited documentation)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978
Reference Type:
other company data
Title:
Unnamed
Year:
2002

Materials and methods

Principles of method if other than guideline:
Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h and the other side was treated for 1, 5 or 15 min under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened with test substance.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Coke (coal), naphtha cracking ethylene manuf. by-product
EC Number:
305-500-5
EC Name:
Coke (coal), naphtha cracking ethylene manuf. by-product
Cas Number:
94581-02-9
Molecular formula:
C
IUPAC Name:
Coke (coal), naphtha cracking ethylene manuf. by-product
Constituent 2
Reference substance name:
Acetylene coke
IUPAC Name:
Acetylene coke
Constituent 3
Reference substance name:
XXVI/564
IUPAC Name:
XXVI/564
Details on test material:
- Name of test material (as cited in study report): Acetylenkoks
- Physical state: solid
- Purity: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.64 and 2.88 kg
no further details

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 1 ml
- Concentration (if solution): 50%, creamy black solution
Duration of treatment / exposure:
Experiment 1: 20 h
Experiment 2: 1, 5, or 15 minutes
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (presumably 1 ml suspension)

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol conc. and 50% (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
20 h exposure
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 2 or 8 d
Remarks on result:
other: Substance residues observed until d5; erythema not observable on d1 due to the residues; scaling observed in 1/2 animals only on d7
Irritation parameter:
edema score
Basis:
mean
Remarks:
20 h exposure
Time point:
other: 24 - 48 - 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
15 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
0
Remarks on result:
other: Substance residues were observed until d7
Irritation parameter:
edema score
Basis:
mean
Remarks:
15 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
0

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation. Descriptive scores of the raw data have been converted to Draize numerical scores.

Applicant's summary and conclusion

Executive summary:

This study meets scientific standards with acceptable restrictions (limited documentation). Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the test substance.

The test substance induced erythema after 20 h occlusive exposure (reversibel within 7 d) in 1/2 animals; 15 min exposure did not cause any irritation effects.

Conclusions

Acetylene coke has to be evaluated as minimal irritating to the skin