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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 March to 25 March 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Species: Wistar outbred rat; Crl:(WI) WU BR
Supplier: Charles River, Germany
Sex and age: females, ca 7-8 weeks old upon arrival
Date of arrival: 26 February 2003
Quarantine/acclimatization: 13 days
Caging: a maximum of six animals per macrolon cage
Lighting: 12 hours light/12 hours dark cycle
Temperature during testing: 22± 3°C.
Relative humidity during testing: 30-70%. Upper limit incidentally up to 100%, because of meteorological circumstances and/or wet cleaning of the animal room.
Ventilation: ca 10 air changes/hour
Diet/water: standard laboratory diet ad libitum. Each batch of this diet is analysed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results are kept available in the archives. Tap water (N.V. Hydron MiddenNederland) ad libitum. Results of routine physical, chemical and microbiological examination of drinking water as conducted by the supplier are kept available in the archives. The results of diet and water analyses were considered acceptable for this study.
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The animals were dosed with a 10 ml/kg body weight of a 200 mg/ml aqueous suspension of the test substance in order to obtain the 2000 mg/kg dose level.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 animals
Control animals:
no
Details on study design:
The study was started with treatment of three females with a dose level of 2000 mg/kg body weight. Since none of the animals died during the following hours, the test was continued with the same dosing of another three females. The animals were dosed with a 10 ml/kg body weight of a 200 mg/ml aqueous suspension of the test substance in order to obtain the 2000 mg/kg dose level. The exact amount of the test substance to be dosed was calculated for each animal individually and administered by means of a syringe, equipped with an oral gavage. Prior to dosing, the animals had fasted overnight.
Approximately 4 hours after dosing, they had access to food again. The animals were observed for mortality up to 14 days after treatment.

Observation and measurements
Clinical signs: All visible reactions to treatment were recorded, including type, severity, onset and duration. Observations were made within 1 hour and within 4 hours after dosing, and subsequently in surviving animals at least once daily throughout an observation period of 14 days.
Body weights: The body weight of each animal was recorded immediately before dosing on day 0, and of the surviving animals on days 3, 7 and 14 of the study.
Termination of the study: At the end of the observation period, on day 14 of the study, all surviving animals were killed with carbon dioxide and examined for external changes. Next, the abdomen and the thorax of each animal was opened and examined for gross pathological changes.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the 14-day study period.
Clinical signs:
other: No clinical signs was observed during the 14-day study period.
Gross pathology:
Examination at necropsy of the animals did not reveal distinct treatment-related gross alterations.
Other findings:
No further findings investigated in this study.

Table 1

Acute oral toxicity of T-1063FM in rats; individual and mean bodyweights, dose amounts applied and mortality

 

Animal no.

Dose (ml) applied1

Bodyweights (g) recorded on day:

Mortality2

0

3

7

14

2000 mg/kg (first group)

35

1.7

173

183

187

202

-

37

1.7

175

191

197

210

-

39

1.8

176

191

198

214

-

Mean bodyweight

175

188

194

209

0/3

(second group)

101

1.7

167

181

189

204

-

103

1.7

172

190

198

212

-

105

1.8

180

195

205

212

-

Mean bodyweight

173

189

197

209

0/3

12000 mg/kg; dose of 10 ml/kg bodyweight of a 200 mg/ml aqueous suspension of the test substance

2- = animal survived; + = animal died

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Since all animals survived the 2000 mg/kg dose level, the oral LD50 of T-1063FM is considered to be higher than 2000 mg/kg body weight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 March to 25 March 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species: Wistar outbred rat; Crl:(WI) WU BR
Supplier: Charles River, Germany
Sex and age: males and females, ca 7-8 weeks old upon arrival
Date of arrival: 26 February 2003
Quarantine/acclimatization: 13 days
Caging: a maximum of five animals per macrolon cage; individual housing during dermal exposure
Lighting: 12 hours light/12 hours dark cycle
Temperature during testing: 22 ± 3°C.
Relative humidity during testing: 30-70%. Upper limit incidentally up to 100%, because of meteorological circumstances and/or wet cleaning of the animal room.
Ventilation: ca 10 air changes/hour
Diet/water: standard laboratory diet ad libitum. Each batch of this diet is analysed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results are kept available in the archives. Tap water (N.V. Hydron MiddenNederland) ad libitum. Results of routine physical, chemical and microbiological examination of drinking water as conducted by the supplier are kept available in the archives. The results of diet and water analyses were considered acceptable for this study.
Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
At the end of the acclimatization period, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. The next day, the test material was applied to the clipped area of 5 male and 5 female rats by weight in one dose level of 2000 mg of the test substance per kg body weight. For this purpose, the animals were dosed with a 4 ml/kg body weight of a 500 mg/ml aqueous suspension of the test substance in order to obtain the 2000 mg/kg dose level. The weight variation of the animals did not exceed plus or minus 20% of the mean body weight at the start of the study. The amount of the test material was calculated for each animal individually and distributed in a thin layer over an area of intact skin, measuring at least 4 x 5 cm. For each animal, the exposure area was at least 20 cm2, i.e. at least 10% of the total body surface of the animals. The exposed area was covered by a gauze, which was fixed to the application site by means of adhesive tape and the entire trunk of the rat was wrapped with a tape to maintain the test patch in position and to retard evaporation of volatile substances. During the exposure period the animals were housed individually. After an exposure period of circa 24 hours the materials and residues of the material applied were removed with water. The animals were observed for mortality up to 14 days after treatment.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Observation and measurements
Clinical signs: All visible reactions to treatment were recorded, including type, severity, onset and duration. Observations were made within 1 hour and within 4 hours after dosing, and subsequently in surviving animals at least once daily throughout an observation period of 14 days.
Body weights: The body weight of each animal was recorded immediately before dosing on day 0, and of the surviving animals on days 3, 7 and 14 of the study.
Dermal reactions: The skin reactions were evaluated by the method of Draize et al. (J. Pharmacol. Exp. Ther. 82 (1944) 377-390). Skin readings were made on day 1 after substance removal, and in surviving animals on days 3, 7, and 14 of the study.
Termination of the study: At the end of the observation period, on day 14 of the study, all surviving animals were killed with carbon dioxide and examined for external changes. Next, the abdomen and the thorax of each animal was opened and examined for gross pathological changes.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the 14-day study period.
Clinical signs:
other: No clinical signs were observed during the 14-day study period.
Gross pathology:
Examination at necropsy of the animals did not reveal distinct treatment-related gross alterations.
Other findings:
No signs of skin irritation were observed during the 14-day observation period.

Table 1

Acute dermal toxicity of T-1063FM in rats; individual and mean bodyweights, dose amounts applied, and mortality

Animal no.

Dose (ml) applied1

Bodyweights (g) recorded on day:

Motrality2

0

3

7

14

2000 mg/kg Males

2

1.1

267

268

285

317

-

4

1.1

274

274

287

319

-

6

1.0

261

263

276

298

-

8

1.1

265

259

273

300

-

10

1.1

272

275

286

318

-

Mean bodyweight

268

268

281

310

0/5

Females

1

0.80

201

202

210

216

-

3

0.74

185

185

192

212

-

5

0.74

185

185

192

205

-

7

0.77

192

187

195

227

-

9

0.78

194

192

197

213

-

Mean bodyweight

191

190

197

215

0/5

12000 mg/kg; dose of 4 ml/kg bodyweight of a 500 mg/ml aqueous suspension of the test suspension

2- = animal survived; + = animal died

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Since all animals survived the 2000 mg/kg dose level, the dermal LD50 of T-1063FM is considered to be higher than 2000 mg/kg body weight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

In both, the acute oral and the acute dermal toxicity studies, all animals survived the limit dose of 2000 mg/kg b.w. Therefore, classification of T-1063 FM for acute oral or dermal toxicity is not required according to REGULATION (EC) 1272/2008. Also classification for acute inhalation toxicity is not required based on the arguments as provided in the waiver of the respective study.