Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 January 2015 - 19 February 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
440/208
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adapted 24 February 1987
GLP compliance:
yes
Remarks:
OECD Principles on Good Laboratory Practice (revised 1997, ENV/MC/CHEM(98)17); and are in accordance with, and implement, the requirements of Directives 2004/9/EC and 2004/10/EC.
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Solid
Details on test material:
Off white

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: none
- Housing: suspended solid floor polypropylene cages furnished with woodflakes
- Diet: (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 10% of the total body surface area

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin and surrounding hair wiped with cotton wool moistened with a suitable solvent to remove any residual test item
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw moistened with arachis oil (BP).
Duration of exposure:
24 hours
Doses:
2,000mg/kg bw
No. of animals per sex per dose:
5 males and 5 females at one dose level of 2,000mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 0.5hr, 1hr, 2hr, 4hr after dosing and subsequently once daily for 14 days.
- Frequency of weighing: Days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: erythema, edema and other.

Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of
2000 mg/kg body weight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Zero mortality
Mortality:
Male: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
One female showed no gain in body weight during the first week but expected gain in body weight during the second week. One other female showed expected gain in body weight during the first week but body weight loss during the second week. The remaining animals showed expected gains in body weight during the study.

Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

Body Weights:

 

 

DoseLevelmg/kg

 

AnimalNumberand Sex

 

Body Weight(g) at Day

 

Body Weight Change(g)During Week

 

0

 

7

 

14

 

1

 

2

 

 

 

 

 

 

 

 

 

 

2000

1-0 Male

239

256

270

17

14

3-0 Male

274

281

335

7

54

3-1 Male

248

260

285

12

25

3-2 Male

260

271

280

11

9

3-3 Male

250

259

282

9

23

2-0 Female

212

217

222

5

5

4-1 Female

228

229

232

1

3

4-2 Female

218

220

217

2

3

4-3 Female

200

203

211

3

8

4-4 Female

212

212

222

0

10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
Executive summary:

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bodyweight

The test item does not meet the criteria for classification according to EU Labelling Regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances, Regulation (EC)No1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures or the Globally Harmonized System of Classification and Labelling of Chemicals.