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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:
8 April 1997 to 27 May 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
Reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony
EC Number:
948-063-1
IUPAC Name:
Reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony
Test material form:
liquid: viscous
Specific details on test material used for the study:
- Description: Amber liquid
- Date received: 7 April 1997

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Externally
- Age at study initiation: Adult
- Weight at study initiation: Females: 2.410 to 2.465 kg, and Males: 2.441 to 2.484 kg
- Housing: Individually in suspended stainless steel cages
- Diet: Certified rabbit feed was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: Minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 69 to 71 °F
- Humidity: 26 to 53 %
- Air changes: 10-15 air changes / hour
- Photoperiod: 12-hour light / 12-hour dark cycle

IN-LIFE DATES:
The in-life phase of the study was initiated with test article administration on April 21, 1997 and concluded with final scoring on April 28, 1997.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
At 1, 24, 48 and 72 hours and up to 7 days after removal of patches
Number of animals:
Six (3 female and 3 male)
Details on study design:
TEST SITE
1 inch x 1 inch area of intact skin for a single dermal application.

REMOVAL OF TEST SUBSTANCE
Excess test substance was removed approximately 4 hours after application.

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours and up to 7 days.

SCORING SYSTEM:
The exposure sites were examined and scored for erythema and edema on a graded scale of 0 to 4 in accordance with the according to the Macroscopic Dermal Grading System based on Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Primary Irritation Index
Basis:
mean
Time point:
24 h
Score:
0.67
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Primary Irritation Index
Basis:
mean
Time point:
48 h
Score:
0.33
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Primary Irritation Index
Basis:
mean
Time point:
72 h
Score:
0.17
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Primary Irritation Index
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Remarks:
Primary Irritation Index
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Remarks:
Primary Irritation Index
Basis:
mean
Time point:
72 h
Score:
0
Irritant / corrosive response data:
Exposure to the test article produced very slight erythema on 5/6 test sites at the 1 hour scoring interval. The dermal irritation resolved completely in all animals by study day 7.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test item was considered to be non-irritant.
Executive summary:

A skin irritation study was conducted via a method that is comparable to the standardized guideline study OECD 404, under GLP conditions. Six (three male and three female) adult New Zealand White rabbits were dosed as the test material was supplied at 0.5 ml to approximately one inch x one inch area of intact skin. The application was a single dermal application with a semi-occlusive coverage for a four-hour treatment period. The patches were removed approximately four hours after application and excess test item was removed. At 1, 24, 48 and 72 hours and up to 7 days after patches removal, the exposure sites were examined and scored for erythema and edema on a graded scale of 0 to 4 in accordance with the according to the Macroscopic Dermal Grading System based on Draize. Exposure to the test material produced very slight erythema on 5/6 test sites at the 1 hour scoring interval. The dermal irritation resolved completely in all animals by study day 7. The irritation indices were 0.67, 0.33, and 0.17 for erythema at 24, 48, and 72 hours, respectively, after patch removal and 0 for edema at all scoring intervals. The test item was considered to be non-irritant.