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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 Dec - 23 Dec 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, UK
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-000-2
EC Name:
-
Cas Number:
647028-25-9
Molecular formula:
This is a UVCB so NA
IUPAC Name:
3-[3-(pentanoyloxy)-2,2-bis[(pentanoyloxy)methyl]propoxy]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: straw coloured liquid
- Analytical purity: UVCB tested
- Storage condition of test material: at room temperature in darkness

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CD (Crl:CD® (SD) IGS BR)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 209-229 g (males) and 204-235 g (females)
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: animals were housed in groups of up to 3 per cage per sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 37-67
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.06 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to the author(s), the information available suggested a starting dose of 2000 mg/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 30 min, 1, 2 and 4 h after dosing and subsequently daily for 14 days and individual body weights were determined prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 according to experimental results
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted (see Table 1).
Gross pathology:
Necropsy revealed no substance-related findings.

Any other information on results incl. tables

Table 1. Individual body weights and weekly body weight changes.

Dose level mg/kg bw

Animal number and sex

Body weight (g) at Day

Body weight gain (g)

during week

0

7

14

1

2

2000

1-0 Female

204

237

249

33

12

2000

1-1 Female

235

262

280

27

18

2000

1-2 Female

225

265

284

40

19

2000

1-0 Male

217

300

352

83

52

2000

1-1 Male

209

284

318

75

34

2000

1-2 Male

229

297

339

68

42

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

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