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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-07-05 to 2000-07-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

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

Test material

Constituent 1
Reference substance name:
ZINN(II)-RICINOLEAT
IUPAC Name:
ZINN(II)-RICINOLEAT
Constituent 2
Reference substance name:
Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride
EC Number:
700-814-2
Molecular formula:
not applicable UVCB substance
IUPAC Name:
Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species : Albino Rabbit, New Zealand White, (SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. EC, OECD)
Source : Charles River Deutschland, Kisslegg, Germany.
Number of animals : 3 Animals of one sex.
Age and body weight : Animals used within the study were at least 6 weeks old and body weights were less than 3.5 kg.
Identification : Earmark.
Conditions : A controlled environment was maintained in the room with optimal conditions considered as being approximately 15 air changes per hour, a temperature of 21°C, a relative humidity of 50% and 12 hours artificial fluorescent light and 12 hours dark per day. Deviations from these optimal conditions were noted, but were considered not to have affected study integrity.
Accommodation : Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet : Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided once a week.
Water : Free access to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent area of untreated skin
Amount / concentration applied:
Each animal was treated by dermal application of 0.5 ml of the test substance.
Duration of treatment / exposure:
The test substance was applied to the skin of one flank, using a metalline patch# of 2x3 cm. The patch was mounted on Micropore tape*, which was wrapped around the abdomen and secured with Coban elastic bandage*. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water and ethanol.
* Supplier: Lohmann GmbH, Neuwied, Germany.
* Supplier: 3M, St. Paul, Minnesota, U.S.A.
Observation period:
The skin reactions were assessed at approximately 1 , 24, 48 and 72 hours and 7 days after the removal of the dressings and test substance.
Number of animals:
3
Details on study design:
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (1 Ox15 cm). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.
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.
Observations:
Mortality/viability : Twice daily.
Toxicity : At least once daily.
Body Weight : Day of treatment (prior to application).
Irritation : The skin reactions were assessed at approximately 1 , 24, 48 and 72 hours and 7 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
No histopathology was performed, since the skin reactions were not masked by test substance staining.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Scaliness was noted in all animals at termination (after 7 days), which was considered to be a reversible skin reaction.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Exposure resulted in well-defined erythema and slight oedema in the treated skin-areas, which had been resolved within 7 days after exposure in all animals. Scaliness was noted in all animals at termination
(after 7 days). The scaliness, seen at termination, was considered to be a reversible skin reaction.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Individual irritation scores:

Animal number:

1 hour

24 hours

48 hours

72 hours

7 days

Average

24 – 72 hours

Erythema:

1

2

2

2

2

0

2

2

2

2

2

2

0

2

3

2

2

2

2

0

2

Edema:

1

2

1

0

0

0

0.33

2

2

1

1

1

0

1

3

2

1

1

0

0

0.67

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Interpretation is based on erythema/eschar and edema calculated as mean scores for each animal following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.The scaliness, seen at termination, was considered to be a reversible skin reaction.
According to CLP, EU GHS (Regulation (EC) No 1272/2008) no classification is required for ZINN(II)-RICINOLEAT



Executive summary:

Primary skin irritation/corrosion study with ZINN(II)-RICINOLEAT in the rabbit (4-hour semiocclusive application).

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, 8.4, "Acute Toxicity - Skin irritation" and OECD No 404, "Acute Dermal Irritation/Corrosion" . Three rabbits were exposed to 0.5 ml of ZINN(II)-RICINOLEAT, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours and 7 days after exposure. Exposure to ZINN(II)-RICINOLEAT resulted in well-defined erythema and slight oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 7 days after exposure in all animals. Scaliness was noted in all animals at termination (after 7 days). Remnants of the test substance were present on the skin of all animals on day 1. The scaliness, seen at termination, was considered to be a reversible skin reaction.

 

Interpretation of study results is based on mean scores for each animal following grading at 24, 48 and 72 hours for erythema and oedema: 

 

·      according to CLP, EU GHS (Regulation (EC) No 1272/2008): not irritating

(mean score erythema or edema 24, 48 , 72 hours of min. 2 of 3 is ≥ 2.3 - ≤ 4.0)

 

·      according to Directive 67/548/EEC: irritating R38

(mean score erythema or edema 24, 48, 72 hours of min. 2 of 3 is ≥ 2) 

The reported scaliness at study termination after 7 days was considered to be a reversible skin reaction.