Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
22 June 1992 - 26 June 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed to OECD test guidelines, and in accordance with GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: animals not fully observed for reversibility of effects
GLP compliance:
yes
Remarks:
Report states that the testing laboratory, Scantox, was accredited by the Danish Accreditation Scheme, however a formal certificate of accreditation was not included.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CTF
- Physical state: A clear, colourless liquid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Purity test date: Not reported
- Lot/batch No.: 9201
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
- Other:
A read across is proposed based on structural similarities between the substances.

Test animals

Species:
rabbit
Strain:
other: SPF Albino
Details on test animals or test system 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 specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5 mL
- Concentration (if solution): Not applicable.
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:
1
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:
0
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 information Criteria 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.