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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:
21 Feb - 04 Mar 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study with acceptable restrictions, in some cases the animals had already been used in earlier studies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
in some cases the animals had already been used in earlier studies.
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
in some cases the animals had already been used in earlier studies.
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts
EC Number:
939-603-7
Cas Number:
1471316-72-9
Molecular formula:
not applicable (UVCB substance)
IUPAC Name:
Benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts
Details on test material:
- Name of test material (as cited in study report): Benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts
- Physical state: liquid, brown
- Analytical purity: 100%
- Lot/batch No.: 06-6923
- Expiration date of the lot/batch: 2008-11-11
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: Crl:KBL(NZW)BR
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adult animals (females)
- Weight at study initiation: 3100 - 3400 g
- Housing: individual housing in Metall/Noryl (EBECO) cages, excrement trays below the cages contained low dust wood granulate bedding.
- Diet: standard diet "Ssniff K-Z" 4 mm (Spezialdiäten GmbH, Soest, Germany), approximately 100 g/animal/day. Hay or hay pellets were offered additionally (hay, irradiated, Harlan Winkelmann GmbH, Borchen Germany; hay pellets, Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%
Duration of treatment / exposure:
Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm² on the dorso-lateral area of the trunk
- Type of wrap if used: The treated skin was covered with a gauze patch, held in place with non-irritating tape for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with water.
- Time after start of exposure: 3 min, 1 and 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: brownish discolouration of the treated skin was observed up to 1 h after patch removal
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: brownish discolouration of the treated skin was observed up to 1 h after patch removal
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: brownish discolouration of the treated skin was observed up to 24 h after patch removal
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Other effects:
No other local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of skin irritation study.  

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

2

0

1

0

1

0

24 h

3

3

2

2

2

1

48 h

2

2

2

1

2

1

72 h

2

1

2

1

2

1

7 d

0

0

0

0

0

0

Mean over 24 + 48 + 72 h

2.3

2.0

2.0

1.3

2.0

1.0

Mean over 24 + 48 + 72 h all animals

2.1

1.4

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: Xi, R38
Executive summary:

The study objective was to determine the irritant / corrosive effects on skin of female albino rabbits (strain Crl:KBL(NZW)BR). The method used complied with the OECD TG 404 and GLP, therefore the sudy is assigned as Klimish 1. 0.5 mL of the pure liquid test substance was applied to the skin of the animal under a gauze patch. The treated skin area was approximately 2.5 cm by 2.5 cm in size. The patch was placed on the dorso-lateral areas of the trunk of each animal and was held in place with non-irritating tape for the duration of the exposure period. After the exposure period the dressing and patch were removed. The exposed skin area was carefully washed with water without altering the existing response, or the integrity of the epidermis. The surrounding untreated skin served as control. In the first step only one animal was used and three test patches were applied successively to this animal. As no serious skin reactions were observed after three minutes, the second patch was applied and removed after one hour. At this stage the observations indicated that with respect to animal welfare the exposure can be allowed to extend to four hours, therefore the third patch was applied and removed after four hours and the responses were graded one hour later. The test was completed using two additional animals, exposed for four hours. The dermal irritation was scored approximately at 1, 24, 48 and 72 hours after patch removal. The dermal irritation was observed after 72 hours therefore the animals were monitored usually on day 7 and 14 after patch removal until the changes had completely subsided. The degree of erythema/eschar formation and oedema formation was recorded as specified by DRAIZE. Any serious lesions or toxic effects other than dermal irritation were also recorded and fully described. As general criteria the body weight of each animal was recorded at the beginning of the study. If clinical findings other than dermal irritations occur they were recorded daily. The mean irritation scores for erythema (redness) and eschar formation at the 24 -h, 48 -h and 72 -h reading points were 2.3, 2.0 and 2.0 for animal 1, 2 and 3, respectively. The mean oedema scores were 2.0, 1.3 and 1.0 for animal 1, 2 and 3, respectively. All skin reactions were fully reversible within 7 days. There were no systemic intolerance reactions. The irritation scores in 2 of 3 animals do not exceed the cut-off values defined in the CLP, therefore the classification as skin irritant is not warranted for this substance.