Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-07-17 to 2014-07-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Light brown viscous liquid
Details on test material:
- Physical state: Light brown viscous liquid
- Analytical purity: 100 %
- Expiration date of the lot/batch: 06 June 2016
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: 8-12 Weeks
- Weight at study initiation: Female: 225 - 247g, Males: 280 - 297g
- Fasting period before study: None
- Housing: Animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24 h exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 2014-07-17 to 2014-07-31

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back and flanks
- % coverage: ca. 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool moistened with distilled water to remove any residual test item.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Specific gravity of test item: 0.893
- Dose volume: 2.24 mL/kg bw
- Constant volume or concentration used: Yes
Duration of exposure:
24 h
Doses:
Single dose level of 2000 mg/kg bw
No. of animals per sex per dose:
5 male/5 female
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days.
- Frequency of weighing: Individual body weights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes, at the end of the study the animals were killed by cervical dislocation and subjected for macroscopic examination.

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
There were no signs of dermal irritation.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy

Any other information on results incl. tables

Individual body weights and body weight changes:

Dose level mg/kg

Animal number and sex

Body weight (g) at Day

Body weight gain (g) during week

0

7

14

1

2

2000

1-0 Male

280

291

308

11

17

1-1 Male

296

304

343

8

39

1-2 Male

286

301

330

15

29

1-3 Male

288

297

310

9

13

1-4 Male

297

306

332

9

26

2-0 Female

225

227

230

2

3

2-1 Female

237

241

246

4

5

2-2 Female

247

250

259

3

9

2-3 Female

245

248

260

3

12

2-4 Female

241

246

257

5

11

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the acute dermal LD50 is higher than 2000 mg/kg bw in rats therefore the substance is not classified according to CLP Regulation (EC) No. 1272/2008.
Executive summary:

Test Guidance

OECD Guideline 402 and EC Method B.3 (Acute Toxicity Dermal)

Method and materials

A group of ten Wistar (RccHanTM:WIST) rats (5 males and 5 females) were given a single dermal application of test item at 2000 mg/kg bw. The test item was placed directly on back and flanks of the skin representing approximately 10 % of the total body surface of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days.

Results

No mortality and no clinical signs were observed during the study. There were no signs of dermal irritation. All animals showed expected gains in body weight over the observation period. No macroscopic abnormalities were observed at necropsy. The combined dermal LD50 was considered to be higher than 2000 mg/kg bw in rats.

Conclusion

Under the test conditions, the acute median dermal LD50 is higher than 2000 mg/kg bw in rats therefore it is not classified according to CLP Regulation (EC) No. 1272/2008.