Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20th May 2008 - 15th July 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-guideline study performed according to OECD guideline 434 used for skin examination according to OECD 404. However, according to Regulation (EC) No 1907/2006, the in vivo skin irritation study does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000 mg/kg body weight).
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Principles of method if other than guideline:
Study was performed in rats according to OECD guideline 434 to investigate acute dermal toxicity.
Within this study a skin examination of the application site was performed according to OECD guideline 404.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) 2,2'-thiobisacetate
EC Number:
246-131-9
EC Name:
Bis(2-ethylhexyl) 2,2'-thiobisacetate
Cas Number:
24293-43-4
Molecular formula:
C20H38O4S
IUPAC Name:
2-ethylhexyl 2-({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)acetate
Details on test material:
- Name of test material (as cited in study report): Di(2-ethylhexyl) thiodiglycolate (Di-2-EHTDG)
- Physical state: slightly yellow to yellow, clear
- Analytical purity: 97.8%
- Main Impurities (identity and concentrations): Mono(2-ethylhexyl)thiodiglycolate; 2-ethylhexyl thioglycolate
- Lot/batch No.: 23015
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33 178 Borchen.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 140 - 163 g
- Housing: Macrolon cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 20 May 2008 To: 15 July 2008

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.04 mL/kg bw
Duration of treatment / exposure:
single dose of 2000 mg/kg bw / 24 hours of exposure
Observation period:
14 d
Number of animals:
sighting study: 1
main study: 4
Details on study design:
TEST SITE
- Area of exposure: dorsal trunk
- % coverage: 10 %
- Type of wrap if used: gauze-dressing and non-irritating tape, fixed with an additional dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed using tap water
- Time after start of exposure: 24 h

SCORING SYSTEM: Skin reaction gradings were performed according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Table 1: Individual skin examination scores after 24h-exposure

 

Skin effect

Erythema

Edema

Scoring [h]a

1

24

48

72

Meanb

1

24

48

72

Meanb

Animal No. /sex

#1 / f

0

0

0

0

0

0

0

0

0

0

#2 / f

0

0

0

0

0

0

0

0

0

0

#3 / f

0

0

0

0

0

0

0

0

0

0

aTimepoint of reading after substance removal subsequent to 24h-dermal exposure

bMean of 24, 48 and 72 h scores

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study results, no classification is required.
Executive summary:

An acute dermal toxicity study according to OECD guideline 434 was performed. Within this study skin examinations were performed in 3 animals using evaluation criteria according to OECD guideline 404 for skin irritation.

Five female Wistar rats were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test substance Di(2-ethylhexyl) thiodiglycolate (Di-2-EHTDG) for 24 h under semiocclusive conditions. The application area comprised at least 10 % of the body surface area. After the exposure residual test substance was removed using tap water. 1, 24, 48 and 72 h after test substance removal the skin reactions was examined and scored according to Draize scheme. No edema or erythema formation was observed in all three rats.