Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 March 2013 to 16 April 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF, 12 Nousan No 8147, 2000
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate from MHRA included in reports
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): TCD

- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Organic
- Physical state: Clear Liquid
- Analytical purity: ca 100%


- Lot/batch No.: M0904
- Expiration date of the lot/batch: 31 December 2013



- Storage condition of test material: Refigerated in the dark

Test animals

Species:
rat
Strain:
other: CD (Hsd SD) albino rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 278-316 g for males and 181-198g for females

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 50 days

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

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 de=ressing and further covered with a waterproof dressing encircled around the trunk of the animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with weak detergent in warm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight

- For solids, paste formed: /no

Duration of exposure:
24 Hours
Doses:
2000 mg.kg bodyweight
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: frequent observations on day of dosing and twice per day until the end of the experimental period. Bodyweight recorded on Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, other: macroscopic pathology
Statistics:
mean body wieghts andweekly individual bodyweight changes recorded. No statistical analysis.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths during study
Clinical signs:
Slight to well-defined erythema was seen in two males (P1, P5) with very slight erythema noted in a further two males (P3, P4) and four females (P6, P8, P9, P10). These reactions had resolved by Day 6 for the males and Day 11 for the females. No dermal reactions were observed in the remaining animals
Body weight:
No adverse effects. All 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.
Other findings:
The acute median lethal dermal dose (LD50) to rats of TCD was demonstrated to be greater than 2000 mg/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute median lethal dermal dose (LD50) to rats of TCD was demonstrated to be greater than 2000 mg/kg bodyweight.