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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
Study period:
22 June 1992 - 26 June 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: animals not fully observed for reversibility of effects
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Batch 9201; clear/colourless liquid

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Møllegard Breeding Centre ApS, Ekby, DK-4623 Lille Skensved
Age at study initiation: Not reported
Weight at study initiation: 2.3 - 2.5 kg
Housing: Kept in single PPL cages, 45 x 55 cm, with perforated floor
Diet (e.g. ad libitum): Rabbits had free access to feed pellets "Altromin 2123"
Water (e.g. ad libitum): Free access to drinking water acidified to pH 2.5 with hydrochloric acid
Acclimation period:At least one week

ENVIRONMENTAL CONDITIONS
Temperature (°C): 21 ± 3°C
Humidity (%): 55 ± 15%
Air changes (per hr): 10
Photoperiod (hrs dark / hrs light): 12 hours light per day (from 06h to 18h)

IN-LIFE DATES
From: 22 June 1992
To: 26 June 1992

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
Amount(s) applied (volume or weight with unit): about 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours. Observations made half an hour after removal of the dressings, and also 24, 48, and 72 hours after application of the test substance.
Number of animals:
4
Details on study design:
TEST SITE
Area of exposure: Two patches 2.5 x 2.5 cm on each animal
Type of wrap if used: Gauze patches were secured with a cross of 1 cm wide adhesive tape, and fixed with Scanpor tape, 4.5 cm width, loosely wound round the trunk. The test site was clipped as closely as possible with an electric clipper on the day before the experiment.

REMOVAL OF TEST SUBSTANCE
Washing (if done): Skin was cleaned with soap and lukewarm water after removal of the dressings
Time after start of exposure: 4 hours

SCORING SYSTEM:
Consistent with system described in OECD test guideline 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Slight erythema seen in one animal from 24 hours onwards, still observed after 72 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours.
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: Oedema not observed
Irritant / corrosive response data:
Very slight erythema was seen on one rabbit which persisted for the duration of the observation period; no signs of erythema or oedema were seen in any of the other three rabbits.
Other effects:
No other effects reported.

Any other information on results incl. tables

Very slight erythema was seen on one rabbit which persisted for the duration of the observation period; no signs of erythema or oedema were seen in any of the other three rabbits.

Mean scores for skin irritation

Observation

0.5h

24h

48h

72h

Mean (24-72h)

Erythema

0.00

0.33

0.33

0.33

0.33

Oedema

0.00

0.00

0.00

0.00

0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
A very mild irritant response was seen in one rabbit: the substance is not classified according to CLP.
Executive summary:

An acute dermal irritation test was performed by Scantox, Denmark on behalf of Perstorp Polyols, Sweden (subcontracted through Toxicon, Sweden), to determine the skin irritant properties of the test substance CTF to rats. The study was conducted to GLP and according to OECD Test Guideline 404. The neat liquid test substance was applied to the skin of four female rabbits for a period of four hours. Observations of the irritant response were made shortly after the removal of the test substance, and 24, 48, and 72 hours after exposure. Very slight erythema was seen on one rabbit which persisted for the duration of the observation period (24 -72 hours); no signs of erythema or oedema were seen in any of the other three rabbits. It was concluded that CTF should not be classified as irritating to skin under the CLP Regulation.