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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 May 1988 - 2 June 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether
EC Number:
293-883-9
EC Name:
1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether
Cas Number:
91648-24-7
IUPAC Name:
2,2-bis(hydroxymethyl)propane-1,3-diol; 3-(prop-2-en-1-yloxy)prop-1-ene
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Crl: CD (SD) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent England
- Age at study initiation: Approximately 4-6 weeks
- Weight at study initiation: 111-152g
- Housing: Metal cages with wire mesh floors
- Diet: Standard laboratory rodent diet (Labsure LAD 1), freely available but prevented overnight prior to and approximately 4 hours after dosing
- Water : From the local supply, ad libitum
- Acclimation period: 8 days prior to start of the study

ENVIRONMENTAL CONDITIONS
- Temperature : 20° to 23°C
- Humidity : 61%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12hrs in each 24hr period

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.10 mL/kg

Doses:
A single dose of 2500 mg/kg bw (preliminary study) and 5000 mg/kg bw (main study)
No. of animals per sex per dose:
2 animals/sex/dose ( preliminary) and 5 animals/sex/dose (main study)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 5 days (preliminary) 14 days (main study)
- Frequency of observations and weighing:Rats were weighed on days 1,8 and 15 and observed for clinical signs each day until the end of the study.
- Necropsy of survivors performed: yes
Statistics:
None required

Results and discussion

Preliminary study:
The results of the preliminarystudy indicates thats the acute lethal oral dose to male and females rats was greater than 2500 mg/kg bw. No deaths occurred in the preliminary study conducted at 2500 mg/kg bw, therefore the main study progressed at a dose level of 5000 mg/kg bw
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortalities for the duration of the study
Clinical signs:
other: Signs of reaction to treatment observed in all rats within one hour of dosing were piloerection, a hunched posture, abnormal gait, lethargy and increased salivation. The only other clinical sign apparent within 5 hours of dosing were , prostration and de
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the study

Any other information on results incl. tables

Individual body weights (g) 

Sex

Body weight (g) at Day

Male

1

8

15

128

218

236

152

237

281

128

235

287

136

166

193

142

202

261

Female

111

161

188

125

175

210

124

167

189

127

171

201

117

161

185

  

Clinical signs

 

Signs

No. of rats in group of 5 showing signs

(Dose g/kg)

5.0

Male

Female

Pilo-erection

5

5

Abnormal body carriage (hunched posture)

5

5

Abnormal gait (waddling)

5

5

Lethargy

5

5

Increased salivation

5

5

Decreased respiratory rate

1

1

Pallor of extremities

1

3

Prostrate

0

1

Abdominal distension

1

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute lethal oral dose to rats of 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether was found to be greater than 5000 mg/kg bw
Executive summary:

In this study performed according to EEC – Directive 84-449, Annex V, Part B and the OECD guideline No. 401 in compliance with GLP, groups of 5 male and 5 female Crl: Cd (SD) BR rats were given a single dose of 5000 mg/kg bw 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether. Prior to the main study, a preliminary study was also conducted in which rats were given a single dose of 2500 mg/kg bw and were observed for 5 days following dosing. No deaths occurred for the duration of the preliminary study and the LD50 was reported as greater than 2500 mg/kg bw. In the main study, Animals were observed for 14 days following dosing, and all animal were examined macroscopically. Rats were weighed on Days 1, 8 and 15 and observed for clinical signs each day until the end of the study. No deaths were recorded for the duration of the study. Clinical signs noticed included signs of prostration and a decreased respiratory rate, pallor of the extremities and abdominal distention in a male. Recovery of these animals was complete by Days 4, 5 and 7. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the study. The LD50 value for male and female animals was greater than 5000 mg/kg/bw. Under the conditions of the study, 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether does not require classification according to Regulation (EC) No 1272/2008