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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Mar - 18 Apr 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 Dec 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of 1-hydroxypentan-2-yl formate and 2-hydroxypentyl formate and pentane-1,2-diol and pentane-1,2-diyl diformate
EC Number:
942-424-7
Molecular formula:
not applicable (reaction mass)
IUPAC Name:
Reaction mass of 1-hydroxypentan-2-yl formate and 2-hydroxypentyl formate and pentane-1,2-diol and pentane-1,2-diyl diformate

Test animals

Species:
rat
Strain:
other: Crl:CD(SD), SPF
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 181.1 - 215.0 g
- Fasting period before study: overnight, approx. 16 h prior and 4 h after dosing
- Housing: 1 animal per cage in stainless wire mech cages (260W x 350D x 210H mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS. Ltd., USA), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 - 24.0
- Humidity (%): 43.5 - 58.5
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Lot/batch no.: MKBS6944V (SIGMA-ALDRICH, Co., USA)

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 300 mg/kg bw, since there is no available toxicity information on the test substance.
Doses:
300 and 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: Animals were observed 30 min and 1, 2, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off of 5000 mg/kg bw according to OECD 423
Mortality:
No mortality was observed at 300 and 2000 mg/kg bw, respectively.
Clinical signs:
No clinical abnormalities were observed in any animal at 300 and 2000 mg/kg bw, respectively.
Body weight:
Normal body weight gains were observed in all animals at 300 and 2000 mg/kg bw, respectively.
Gross pathology:
No grossly visible evidence of morphological abnormalities was observed in any animal at 300 and 2000 mg/kg bw, respectively.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study in rats a LD50 > 2000 mg/kg bw was found.
Executive summary:

There were no deaths ofany animals at300 and 2,000 mg/kg. No test substance-related effects were observedin clinical signs, body weight data or necropsy findings in any animalat 300 and 2,000 mg/kg.

Based on the resultof the acute oral toxicity study in Sprague-Dawleyrats, the test substance, was classified to be Category 5 or Unclassified according to the GHS classification and the median lethal dose derived was: LD50 cut off≥ 5,000 mg/kg b.w.