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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:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hostapur SAS 93
- Physical state: solid (delivered by the sponsor as moisturized paste with sesam oil as vehicle)
- Analytical purity: 100% (93% active = CAS RN 85711-69-9)
- Composition of test material, percentage of components: 100% Hostpur SAS 93
- Isomers composition: n.a.
- Purity test date: 2006-03-27
- Lot/batch No.: 2703061
- Expiration date of the lot/batch: 2008-04-01
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: in darkness at room temperature
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Paulistec (Mairipora, SP)
- Age at study initiation: young adult rabbits
- Weight at study initiation: 2410g, 1979g, 2160g
- Housing:
Animals were housed individually in stainless steel cages (50x50x50cm)
- Diet (e.g. ad libitum):
Filtered water and pelleted commercial diat for the species (Guabi, Santa Fé) were provited ad libitum throughout acclimatization and test periods;
food and water were analysed and monitored by TECAM/SP throughout the year for environmental contaminants.
- Acclimation period:
Animals were acclimatized for at least 5 days prior to dosing in a controlled room; all the animals were inspected during this period; animals
exhibiting abnormal signs during this period were not used for the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 23°C
- Humidity (%): 66%
- Photoperiod (hrs dark / hrs light): 12hrs on and 12hrs off

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
other: sesam oil
Controls:
other: second shaved region on each rabbit
Amount / concentration applied:
Dosing of administration was 0.5g.
Duration of treatment / exposure:
4 hours
Observation period:
The period of observation was 1h 24h, 48h, 72h and 7 d for evaluation of oedema and erythema.
Number of animals:
3 male rabbits
Details on study design:
Test substance was applied undiluted as received (paste moisturized with sesam oil as vehicle) to the chosen areas of the skin (6cm²), covered with
a semiocclusive gauze patch und held in place with non-irritating tape. Adjacent non-treated areas were used as control. At the end of a 4 exposure
period, residual test substance was removed using water.

SCORING SYSTEM:
Animals were graded separately after patch removal according to the Draize method (OECD 2002).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 3 animals
Time point:
other: 1h / 24h / 48h / 72h / 7d
Score:
0.6
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1h / 24h / 48h / 72h / 7d
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1h / 24h / 48h / 72h / 7d
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1h / 24h / 48h / 72h / 7d
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all 3 animals
Time point:
other: 1h / 24h / 48h / 72h / 7d
Score:
0.9
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1h / 24h / 48h / 72h / 7d
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1h / 24h / 48h / 72h / 7d
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1h / 24h / 48h / 72h / 7d
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
see table 1

Any other information on results incl. tables

table 1: Individual irritation scores

 Animal No.  Reading Time Point  Oedema Score  Erythema Score
 1   1 hour  0  1
 1  24 hours  0  1
 1  48 hours  0  1
 1  72 hours  0  0
 1   7 days  0  0
 2   1 hour  1  1
 2  24 hours  1  1
 2  48 hours  0  1
 2  72 hours  0
 2   7 days  0  0
 3   1 hour  1  1
 3  24 hours  2  1
 3  48 hours  1  1
 3  72 hours  1
 3   7 days  0  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, sec-alkane sulfonate-sodium salts SAS (93%) is not a skin irritant based on GHS and EU criteria.
Executive summary:

Three adult and healthy New Zealand albino rabbits (Oryctolagus cuniculus) received a single application of the test substance to 6cm² of skin for 4h at a dose of 0.5g. Non-treated areas were used as control.

At the end of 4 hours, residual test substance was removed using water. The animals were observed for 1h, 24h, 48h, 72h und 7 days. Irritation was scored according to the Draize method. No signs of oedema were observed in one animal at 24h. 48h and 72h while one animal presented oedema at 24h und another one presented oedema at 24h, 48h und 72h. Signs of erythema were observed in one animal at 24h and 48h while two animals presented erythema at 24h, 48h und 72h. All findings were fully reversible. Neither systemic toxicity nor abnormality in body weight gain was observed during the observation period.

According to the obtained scores, it was concluded that, under the test conditions, sec-alkane sulfonate-sodium salts SAS (93%) in the delivered form was not irritant (category 4 on the GHS classification of chemicals which cause skin irritation/corrosion). In addition, the following classification und labelling recommendations concerning EU standards are based on the criteria layed down in Council Directive 67/548/EEC on the approximation of the laws, regulations und administrative provisions relating to the classification, packaging and labelling of dangerous substances und subsequent revisions. Based on the results of‘ this study and in line with a.m. directive, sec-alkane sulfonate-sodium salts SAS (93%) is not subject for labelling und classification requirements with regard to skin irritation properties.