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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Reversibility:
other: no signs of irritation were observed
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)