Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2001-04-04 to 2001-04-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

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

Test material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: no
- Housing: individually in suspended polypropylene cages during the 24-hour exposure period and in group of 5 by sex for the remainder
of the study.
- Diet: 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): 15
- Photoperiod: 12 hrs dark /12 hrs light

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area
- % coverage: approximately 10%
- Type of wrap :piece of surgical gauze placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied : 2000mg/kg bw undiluted
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for death or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight and gross pathological examination.
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Mortality:
Male: no mortalities
Female: no mortalities
Clinical signs:
There were no signs of systemic toxicity during the study period.
Body weight:
The body weight gain was not affected by treatment with the test substance.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Dermal reactions (local):
-There were no signs of dermal irritation in males.
-Crust formation was noted at the treatment sites of 3 females 4 and 5 days after treatment. Hardened light brown-coloured scabs, which precluded evaluation of erythema and oedema, were noted in the 2 remaining females 4 to 14 days after dosing.

Any other information on results incl. tables

Table 7.2.1/1: Weekly Bodyweight changes

Dose level mg/kg b.w

Sex

Bodyweight Gain (g) during Week

1

2

2000

F

23

17

F

19

27

F

15

24

F

11

26

F

21

10

M

27

56

M

39

62

M

48

64

M

64

42

M

72

50

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortalities were noted in rats treated by dermal route with a single dose of 2000 mg/kg bodyweight.
Therefore, the substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.
Executive summary:

The dermal toxicity of the substance was tested in rats according to OECD 402 and EU B.3 guidelines. The test item was applied to the back of 5 male and 5 female Spragues-Dawley rats at a concentration of 2000 mg/kg bw. It was covered in gauze and allowed to be in contact with the skin for 24 hours. The animals were observed for 14 days and mortality, body weight, and clinical observations were recorded.

No mortality was observed during the study period. Animals showed expected gains in bodyweight over the study period. Following necropsy and macroscopic examination of internal organs, no abnormalities were detected.

There were no signs of dermal irritation in males. Skin reaction noted at the treatment sites of females included crust formation and hardened light brown-coloured scabs, which precluded evaluation of erythema and oedema.

The dermal LD0 in the study was equal or higher than 2000 mg/kg bw.