Registration Dossier

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:
2008-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF, 12 Nousan, Notification No 8147
Version / remarks:
November 2000, including the most recent partial revisions
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
SPF-Quality. Source: Harlan France SARL, Gannat, France.
Details on test animals and environmental conditions:
Age and body weight Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.
Identification: Earmark.
A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.

Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +- 3.0°C (actual range: 21.8 —22.7°C), a relative humidity of 30-70% (actual range: 42 - 63%) and 12 hours artificial fluorescent light and 12 hours darkness per day.

Accommodation
Individually in labelled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

Diet
Pelleted diet for rabits (K-H from SSNIF Spezialdiäten GmbH, Soest, Germany) approx. 100 g. per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.

Water
Free access to tap-water.

Results of analysis for each batch of diet (nutrients and contaminants), hay and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 0.4 mL of the vehicle and applied to the skin of one flank, using
a metalline patch‘ of 2x3 cm.
Duration of treatment / exposure:
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50% v/v)
Observation period:
1, 24, 48 and 72 hours after removal of the test substance
Number of animals:
3
Details on study design:
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 2 weeks later, after
considering the degree of skin irritation observed in the first animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin irritation was caused.
No evidence of corrosive effect on the skin.
Other effects:
Green-blue staining of the treated skin by the test substance was observed in all animals on days 1 and/or 2. The staining did not hamper the scoring of skin reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results SULFOBUTYL TMBI does not have to be classified and has no obligatory labeling requirement for oral toxicity according to the:
- Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007),
- Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures,
- EC criteria for classification and labeling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this
Directive published in the Official Journal of the European Communities).