Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 April to 16 April 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD, EEC, EPA and JMAF guidelines and in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

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
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Guideline:
other: JMAFF 12 Nousan No 8147, 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate of Compliance from UK GLP Monitoring Authority.
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTF

- Substance type: Organic
- Physical state: Transparent liquid
- Analytical purity: ca 100%
- Lot/batch No.: M1204
- Expiration date of the lot/batch: 31 December 2015
- Storage condition of test material: rom temperature (ca 20 deg C) under nitrogen.
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: UK
- Age at study initiation: approximately 8-12 weeks prior to dosing
- Weight at study initiation: Males: 295 - 308 g; Females 185 - 207 g
- Fasting period before study:
- Housing: individually form Days -1 until Day 11 and then group housed (5 rats of same sex) until end of study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 Days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 40-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 02 April 2013 To: 16 April 2013

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:

TEST SITE
- Area of exposure:50mm x 50mm
- % coverage: 10%
- Type of wrap if used: porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the
trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, weak solution of detergenr in warm water.
- Time after start of exposure: 24 hrs after start of exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.89 ml/kg bodyweight
- Concentration (if solution): 1.061 g/ml
- Constant volume or concentration used: yes


Duration of exposure:
24 hours
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5 per sex
Control animals:
not required
Details on study design:
A group of ten rats (five males and five females) received a single topical application of the test substance, as supplied, at a dose level of 2000 mg/kg
bodyweight, for duration of 24 hours. The animals were retained for a 14 day observation period during which clinical signs, dermal reaction and bodyweight investigations were performed. All animals were humanely killed and examined macroscopically on Day 15, the end of the observation period.

Results and discussion

Preliminary study:
There were no deaths and no systemic response to treatment in any animal. Very slight erythema (barely perceptible) was seen in four males and five females. These reactions had resolved by Day 11. A bodyweight loss was noted for four females on Day 15. All other animals were considered to
have achieved satisfactory bodyweight gains throughout the study.
No abnormalities were noted in any animal at the macroscopic examination at study
termination on Day 15.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
Very slight erythema (barely perceptible) was seen in four males and five females. These reactions had resolved by Day 11.
Body weight:
A bodyweight loss was recorded for four females (EE6 - EE9) on Day 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The acute median lethal dermal dose (LD50) to rats of MTF was demonstrated to be greater than 2000 mg/kg bodyweight.