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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:
1st September 1992 to 11th September 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
other: read-across target
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
Read Across to Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) (EC Number 248-227-6 and CAS No 27107-89-7) based on structural similarity and hydrolytical behaviour, see attached justification.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: All three animals are a erythema score mean of 2
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: All three animals are a edema score mean of 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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:
Octyltin tris(2-EHMA) [CAS No. 27107-89-7]:Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1] (70:30% mixture); colorless liquid.
IUPAC Name:
Octyltin tris(2-EHMA) [CAS No. 27107-89-7]:Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1] (70:30% mixture); colorless liquid.
Details on test material:
Octyltin tris(2-EHMA) [CAS No. 27107-89-7]:Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1] (70:30% mixture); colorless liquid.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: NDA
- Weight at study initiation: 2350 - 2670 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark


IN-LIFE DATES: From: 1st September 1992 To: 11th September 1992

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: control patch on left side of the animal.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): N/A


VEHICLE
- N/A
Duration of treatment / exposure:
4 hours
Observation period:
10 days.
Skin observations recorded at 1, 24, 48 and 72 hours according to the OECD scoring system.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 12 - 16 cm²
- % coverage: NDA
- Type of wrap if used: gauze patch covered with aluminium foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed
- Time after start of exposure: N/A


SCORING SYSTEM: OECD 404 scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: All three animals are a erythema score mean of 2
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: All three animals are a edema score mean of 1
Irritant / corrosive response data:
Because reactions were observed within 7 days after removing the bandages, the observation period was extended to 10 days to determine the reversibility of the skin reactions. Scaling was observed in all animals on day 7. The skin reactions observed were reversible until the end of the observation period on day 10.
Other effects:
None

Any other information on results incl. tables

Table 1. Individual skin reaction scores.

  Erythema Edema
Animal number 738/F
CF/TF
856/F
CF/TF
720/F
CT/TF
738/F
CF/TF
856/F
CF/TF
720/F
CT/TF
After 1 hours 0/2 0/2 0/2 0/1 0/1 0/2
After 24 hours 0/2 0/2 0/2 0/1 0/1 0/1
After 48 hours 0/2 0/2 0/2 0/1 0/1 0/1
After 72 hours 0/2 0/2 0/2 0/1 0/1 0/1
Mean 24-72 hours 0/2 0/2 0/2 0/1 0/1 0/1
After 7 days 0/1s 0/1s 0/1s 0/0 0/0 0/0
After 10 days 0/0 0/0 0/0 0/0 0/0 0/0

Table 2. Individual bodyweights.

Animal number 738/F 856/F 720/F
At start of test 2350 2670 2560
After 3 days 2360 2780 2500
After 7 days 2470 2900 2700
After 10 days (end) 2580 2990 2750

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
Under the conditions of this study the test material was not irritating to rabbits.
Executive summary:

The test material was applied to the skin of female New Zealand White rabbits via an occlusive patch. The test was conducted according to the standardised guideline OECD 404 and performed to GLP. The patch was applied for 4 hours and the rabbits were then observed for 10 days.

Under the experimental conditions employed the test material induced erythema and oedema reactions when applied to the clipped albino rabbit skin. The reactions were reversible until the reading of 10 days after application.

Under the conditions of this study the test material was not irritating to rabbits.