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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1996/07/10-1996/07/25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. The study is considered reliability 1. The read-across is considered reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Kalcohl 0898

- Physical state: a clear colourless liquid.

- Analytical purity: Not specified but a note made that purity was the responsibility of the sponsor.

- Lot/batch No.: 2229

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Froxfield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England.

- Age at study initiation: ca. 3 months

- Weight at study initiation: 2.22-2.64kg

- Housing: The animals were individually housed in suspended stainless steel cages mounted in mobile batteries. The cages were fitted with perforated counter sunk floor panels. A tray beneath the floor was lined with absorbent paper which was changed regularly.

- Diet: (ad libitum) Standard pelleted rabbit diet (STANRAB (P) SQC Special Diets Services Limited, Witham, Essex, England). The diet contained no added antibiotic or other chemotherapeutic or prophylactic treatment. Samples of diet were taken for analysis at six-monthly intervals to detect the potential contaminants by a laboratory independent of the supplier.

- Water: Tap water (ad libitum)

- Acclimation period: Length of the acclimatization period not specified but in place.


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 18C (range 15-23C)

- Humidity (%): 55% R.H (range 40-70%)

- Air changes: 10 complete air changes (per hr)

- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: Not stated.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipped dorsa
Vehicle:
unchanged (no vehicle)
Controls:
other: A control patch on the same animal without test substance.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 ml of test material was applied.

- Concentration (if solution): undiluted


Duration of treatment / exposure:
4 hour(s)
Observation period:
Dermal reactions were assessed at 1,24,48 and 72 hours after removal of the dressing and on days 7, 10, 13 and 16.
Number of animals:
3 females
Details on study design:
TEST SITE

- Area of exposure: Two test areas were marked on either side of the clipped area of dorsum.

- % coverage: 6x6cm patch

- Type of wrap if used: Unmedicated gauze patch (3x2cm) which was held in place on the left test by strips of Blendern (Community Care Products, 3M Health Care, Loughborough, England). The right test site, acting as a control was covered by similar semi-occlusive dressing but remained untreated.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The treatment site was gently washed with warm water and dried with paper tissues to remove excess test material adhering to the skin.

- Time after start of exposure: 4 hours


SCORING SYSTEM: Reactions of the test sites were assessed according to the criteria of Draize 1959.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
group mean
Time point:
other: 24, 48 and 72 hours
Score:
1.43
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: The mean values for erythema and oedema did not equal or exceed the EEC limit values considered to indicate a significant inflammatory response to treatment.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
AVERAGE SCORE

- Erythema: Individual mean 24+48+72 hour scores 1.0, 2.0 and 1.3. 
Other effects:
OTHER EFFECTS: 

The test site was sticky to touch at 1hour post-dosing. A loss of elasticity at the test site was reported at 48 and 72 hours. From day 7 until the end of the observation period (day 16) exfoliation was observed in all test animals. Control sites showed no skin irritation all scores 0.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The C8 alcohol Kalcohl 0898 is not a skin irritant according to either EU criteria following a 4 hour semi-occlusive exposure. Kalcohl 0898 can be considered as a mild irritant under GHS criteria.

Classification: not irritating