2-Propyn-1-ol, compd. with 2-methyloxirane (1:?)

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: comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Golpanol PAP

IUPAC Name:

Golpanol PAP

Details on test material:

- Name of test material (as cited in study report): Golpanol PAP / 2-Propyn-1-ol, compd. with methyloxirane
- Physical state: liquid
- Analytical purity: approx. 50%
- Impurities (identity and concentrations): < 1% Propargyl alcohol, approx. 35% water, approx. 7% Propylene glycol, approx. 7% higher alcoxylated products

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Weight at study initiation: male (mean) = 2.63 Kg, female = 2.54 Kg
- Housing: stainless steel cages (40 x 51 cm) with wire mesh walk floors, one animal per cage, no bedding, saw-dust in waste trays
- Diet (e.g. ad libitum): 130g per animal per day
- Water (e.g. ad libitum): 250ml tap water per animal per day
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animals

Amount / concentration applied:

0.5 ml undiluted test substance

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: upper third of the back or flank
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: test patches were secured with four layers of absorbent gauze and a porous bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4 hours washed with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 72 hours

SCORING SYSTEM: as described in OECD 404 test guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Reversibility:

other: no signs of irritation were observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Reversibility:

other: no edema was observed

Any other information on results incl. tables

The test substance did not cause any edema or erythema except of one male which developed a very slight erythema extending beyond the area of exposure after 4 hours which was fully reversible within 20 hours.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification: not irritating