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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: GLP guideline study with acceptable restrictions. Only 7 days of observation period.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Only 7 days observation period
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Only 7 days observation period
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): α-Olefinsulfonate (4192), C14-C16-α-Olefinsulfonate, Sodium salt
- Physical state: faint yellow powder
- Analytical purity: 95% active
- Composition of test material, percentage of components: 3% Na2SO4; 2% residual oil
- Purity test date: 18 May 1994
- Lot/batch No.: E06184192 from 01 March 1994
- Expiration date of the lot/batch: 31 December 1994
- Storage condition of test material: dark at room temperature under extractor hood
- Other: pH 5 (1% in water)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik, Dr. Karl Thomae GmbH, 88400 Biberach, SPF breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 2.8 - 3.8 kg
- Housing: individually in fully air conditioned rooms
- Diet: Altromin 2123 maintenance diet for rabbits, Altromin-GmbH, Lage/Lippe, ad libitum, and hay, ca. 15 g daily)
- Water: tap water from automatic drinking trough, ad libitum
- Acclimation period: 6 days

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened with 0.4 ml 0.9% NaCl-solution
Duration of treatment / exposure:
4 hours
Observation period:
30 to 60 min, 24, 48 and 72 hours, 7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk was shaved on an area of 25 cm² with electric clippers. Only animals with intact skin were used.
- Type of wrap if used: Moistened test substance was applied to 2.5 x 2.5 cm cellulose patches covered with adhesive tape. The patch was secured to the prepared skin site and covered with a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, substance remnants were carefully removed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize, evaluations were done 30 - 60 min and 24, 48 and 72 hours after patch removal. As effects were observed 72 hours after removal additional readings were performed after 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: fine scales observed at the end of observation period
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed
Remarks on result:
other: dry rough skin after 3 and 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: dry rough skin after 2 and 3 days, fine scales with desquamation after 7 days
Irritant / corrosive response data:
30 min until 72 hours after patch removal the treated skin demonstrated barely perceptible (grade 1) to well defined (grade 2) erythema and very slight (grade 1) to slight (grade 2) edema. The skin surface was dry and rought and demonstrated fine scales which were still visible in 2/3 animals after 7 days, the end of the observation period. Additionally, desquamation of fine scales was observed in 1/3 animals.

Any other information on results incl. tables

The test substance has to be classified as "Irritating to skin" (R38) according to the criteria of the DSD and as Skin Irrit. 2 (H315: Causes skin irritation) according to the criteria of the CLP regulation.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
EU Directive 67/548/EEC: Skin irrit 2, H315
Regulation (EC) No 1272/2008: Xi, R38