Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 05 May to 11 June 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colourless liquid
Details on test material:
- Name of test material (as cited in study report): Propylidynetrimethyl trimethacrylate
- Physical state: colourless liquid
- Storage condition of test material: in a sealed container, at room temperature in the dark

Test animals

Species:
rat
Strain:
other: HsdHan:WIST
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: from 195 to 229 g
- Fasting period before study: overnight prior to dosing until 3 h after dosing
- Housing: in groups of up to five during the acclimatisation period. From the day prior to dosing (Day –1), the rats were housed in groups of three.
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1 (Special Diets Services Ltd, Witham, UK ), ad libitum except during fasting period
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 21 to 23 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 May 2010 To: 11 June 2010

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Volume applied: 1.82 mL/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
None

Results and discussion

Preliminary study:
No data
Effect levels
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No clinical signs were seen.
Body weight:
All rats gained weight during the first and second weeks of the observation period.
Gross pathology:
Red foci on the thymus, a large mandibular lymph node and red foci on the mandibular lymph node were noted at necropsy on one animal.
No abnormalities were noted at necropsy of all other animals.
Other findings:
No data

Any other information on results incl. tables

Table 1: Individual body weights and weekly increments

Dose level (mg/kg bw)

Animal number

Body weight (g) at:

Increment (g)

Day -1

Day 1

Day 4

Day 8

Day 15

Day 1

to 8

Day 8

to 15

2000

40

195

183

189

204

208

21

4

41

229

217

220

244

257

27

13

42

208

195

200

218

229

23

11

2000

43

209

201

209

215

225

14

10

44

214

200

211

217

232

17

15

45

216

208

217

221

236

13

15

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 for propylidynetrimethyl trimethacrylate is higher than 2000 mg/kg bw in rats.
Executive summary:

In an acute oral class method toxicity study performed in accordance with GLP and OECD guideline 423, 6 Sprague Dawley female rats were given a single oral dose of propylidynetrimethyl trimethacrylate at the limit test dose of 2000 mg/kg bw.

Clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.

No mortality, no clinical signs, no change in body weight and no abnormalities in macroscopic examination of main organs were observed except red foci on the thymus, a large mandibular lymph node and red foci on the mandibular lymph node in one animal.

The oral LD50 for propylidynetrimethyl trimethacrylate is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation(EC) N° (1272-2008).