1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

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

Test material information

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

Molecular formula:

C14H24O4

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