2-Propyn-1-ol, reaction product with 1-2.5 moles of oxirane

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, Source substance for RA information according to analogue justification.

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:

Reaction product of 2-Propyn-1-ol with methyloxirane

EC Number:

609-530-2

Cas Number:

38172-91-7

IUPAC Name:

Reaction product of 2-Propyn-1-ol with methyloxirane

Details on test material:

- 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

Executive summary:

According to OECD 404, skin irritation was tested without GLP compliance. The applicant site of 2,5 x 2,5cm of 3 white Vienna rabbits was exposed for 4h to undiluted test item using semiocclusiv conditions and washed with Lutrol and Lutrol/water (1:1) followed by a 72 hours observation period with readings after 30 min and 60 min after the removal of the test patches and 24 h, 48 h and 72 h after the beginning of application. Untreated skin sites of the same animal were used as negative control.

No signs of irriation or corrosion were observed at any time. Based on this study, the test substance could be classified as non irritating. (BASF, 1987)