Ethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

hypothesis As a hypothesis, methanol is the critical constituent of the substance (S-Ethanol, composition 2) based on its amount and with regards to its hazardous properties. It is the major constituent affecting the classification and labeling of the target substance (S-Ethanol). Therefore, data from methanol is used in the read-across approach in order to update the hazard assessment of this substance. Other impurities are taken into account for self-classification but there were no need to consider evaluating their properties in hazard assessment because of low concentrations. Analogue approach justification This substance (S-Ethanol, composition 2) has degree of ethanol purity between 76.4-81.9 %. Methanol is the main impurity of the target substance (conc. 13-14 %), and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For chemical safety assessment certain physico-chemical properties are relevant for both human health and environmental health assessment. Also they are important for self-classification and for updating of the exposure assessment of the target substance. For toxicological endpoints, methanol is considered the major drivers for classification and overall safety assessment of the target substance. Therefore, methanol properties were included for chemical safety assessment and the endpoint robust summaries were provided also for methanol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

Study performed according to internal company standards (BASF-test) before actual guideline was adopted.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methanol

EC Number:

200-659-6

EC Name:

Methanol

Cas Number:

67-56-1

Molecular formula:

CH4O

IUPAC Name:

methanol

Details on test material:

- Name of test material (as cited in study report): methanol, not further specified
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

Vienna White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): unspecified amount
- Concentration (if solution): 100 % (undiluted)

Duration of treatment / exposure:

1, 5, 15 min and 20 hours (ear: only 20 hours)

Observation period:

24, 48, 72 hours, 6 days and 8 days after beginning of application (exception: application time 20 hours: no observations after 24 hours)

Number of animals:

2 (1, 5 and 15 min); 2 (20 hours)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm area of skin on the back and the ear
- % coverage: not specified (application site 2.5 x 2.5 cm)
- Type of wrap if used: cotton pad soaked with the undiluted test substance, covered by an impervious bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water, sometimes containing a mild detergent
- Time after start of exposure: 1, 5, 15 min, 20 hours (after the application)

SCORING SYSTEM: BASF scoring system, convertible to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritant / corrosive response data:

After 1, 5, 15 min of exposure, no signs of irritation (erythemy, edema) were apparent after 24, 48 and 72 hours and after 6 and 8 days. After 20 hours of exposure no signs of irritation (erythema, edema) were apparent after 48 and 72 hours and after 6 and 8 days

Other effects:

No mortality occurred. There were no clinical signs of systemic toxicity from the dermal exposure.

Any other information on results incl. tables

No individual animal scores given in the report

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information