Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-950-7
EC Name:
-
Cas Number:
187393-00-6
Molecular formula:
C38-H49-N3-O5
IUPAC Name:
5-[(2-ethylhexyl)oxy]-2-(4-{4-[(2-ethylhexyl)oxy]-2-hydroxyphenyl}-6-(4-methoxyphenyl)-1,3,5-triazin-2-yl)phenol
Details on test material:
- Name of test material (as cited in study report): CFG-C-1607
- Physical state: yellow solid
- Analytical purity: >98%
- Lot/batch No.: 002
- Expiration date of the lot/batch: 31 Aug 1998
- Stability under test conditions: stable in PEG 400 for at least 48 hours
- Storage condition of test material: in the original container at room temperature away from direct sunlight

Test animals

Species:
rat
Strain:
other: HanIbm: WIST
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, 4414 Fullinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks; Females: 11 weeks
- Fasting period before study: 16 hours
- Weight at study initiation: Males: 231.7 - 256.9 g; Females: 190.4 - 219.8 g
- Housing: Groups of five in Makrolon type -4 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch nos 81/96 and 84/97 rat maintenance diet available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itengen, available ad libitum
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees centigrade
- Humidity (%): 40 - 70%
- Air changes (per hr):10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
(PEG 400)
Details on dermal exposure:
TEST SITE
- Area of exposure: backs
- % coverage: 10
- Type of wrap if used: elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: 24 hrs

TEST SOLUTION
- Amount(s) applied (volume or weight with unit): 4 ml/kg bw
- Concentration of test material: 0.5 g/ml
- Dose: 2000 mg/kg bw
- For solids, paste formed: no (suspension in PG400)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily, with weighings on days 1 (prior to exposure), 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
None, as no deaths ocurred.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: None
Gross pathology:
No abnormalities

Any other information on results incl. tables

 

Group / Sex

Animal

Day 1

Day 8

Day 15

1 / Males

(2000 mg/kg bw)

1

245.8

271.9

299.9

2

243.4

265.0

299.1

3

256.9

284.0

320.2

4

242.5

272.9

306.1

5

231.7

266.5

300.1

Mean

244.1

272.1

305.1

+S.D.

9.0

7.5

8.9

N

5

5

5

1 / Females

(2000 mg/kg bw)

6

209.4

211.0

220.7

7

206.4

207.5

214.5

8

219.8

225.5

229.0

9

219.5

227.5

237.8

10

190.4

204.4

212.6

Mean

209.1

215.2

222.9

+S.D.

12.0

10.6

10.5

N

5

5

5

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality, clinical signs of toxicity, or macroscopic abnormalities were observed at the dermally applied limit dose of 2000 mg/kg bw.