Coke (coal), naphtha cracking ethylene manuf. by-product

Skin irritation / corrosion

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

20 h exposure

Time point:

other: 24 - 48 - 72 h

Score:

0

Results 3

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

Results 4

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