4-Octanol, 3-amino-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Recently conducted OECD Guideline study conducted according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-070-6

EC Name:

-

Cas Number:

1001354-72-8

Molecular formula:

C8-H19-N-O

IUPAC Name:

(3R,4R)-3-aminooctan-4-ol; (3R,4S)-3-aminooctan-4-ol; (3S,4R)-3-aminooctan-4-ol; (3S,4S)-3-aminooctan-4-ol

Details on test material:

The Test material was Octanolamine ( XU-12314.00)

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

175 mg/kg bw
550 mg/kg bw
2000 mg/kg bw

No. of animals per sex per dose:

175 mg/kg bw - 2 female;
550 mg/kg bw - 3 female;
2000 mg/kg bw - 1 female

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 550 mg/kg bw

Mortality:

550 mg/kg (3 animals):
2 animals died during the study (1 on day 0 and 1 on day 1)

2,000 mg/kg (1 animal):
This animal died within 2 hours of test substance administration.

Clinical signs:

other: 175 mg/kg (2 animals): Both animals appeared active and healthy during the study - there were no adverse clinical signs, signs of gross toxicity or abnormal behaviour. 550 mg/kg (3 animals): Clinical signs noted prior to death included hypoactivity, pro

Gross pathology:

175 mg/kg (2 animals):
There were no abnormalities noted at necropsy.

550 mg/kg (3 animals):
Gross necropsy of the decedents revealed discoloration of the intestines. No gross abnormalities were noted for the euthanized animal necropsied at the conclusion of the 14 -day observation period.

2,000 mg/kg (1 animal):
Clinical signs noted prior to death included hypoactivity, hunched posture and piloerection.

Any other information on results incl. tables

Summary of results:

Animal number	Sex	Dose Level (mg/kg)	Bodyweight (g)			Dose ^2 (ml)	Mortality^1 (day)
			Initial	Day 7	Day 14
3101	F	175	143	150	162	0.029	E
3103	F		130	137	149	0.026	E
3102	F	550	135	-	-	0.082	0
3104	F		123	136	148	0.075	E
3106	F		130	-	-	0.079	1
3105	F	2000	130	-	-	0.29	0

1 - E - Euthanized via CO2 inhalation after weighing on Day 14

2 - The test substance was administered as received. Specific Gravity – 0.897 g/mL.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

XU-12314.00 appears to have moderate to low acute toxicity, with an LD50 of approximately 550 mg/kg.

Executive summary:

An acute oral toxicity test (Up and Down Procedure) was conducted with Fischer 344 rats to determine the potential for XU-12314.00 to produce toxicity from a single dose via the oral route. Under the conditions of this study, the acute oral LD50 of XU-12314.00 was estimated to be 550 mg/kg (the one dose with partial response) of body weight in female rats with a 95% PL confidence interval of 88.94 mg/kg (lower) to 2,430 mg/kg (upper).