1-Octanol, reaction products with epichlorohydrin and 2-mercaptoethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

473-730-4

EC Name:

-

Cas Number:

928768-73-4

Molecular formula:

C13H28SO3

IUPAC Name:

1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol

Test material form:

liquid: viscous

Details on test material:

Lot/batch # 19381-92

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were identified by cage notation and indelible body marks, and housed in suspended wire mesh cages; 5/sex/cage prior to dosing and 3/sex/cage following dosing. Bedding was placed beneath the cages and changed at least three times/week. Fresh PMI Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing. Water was freely available at all times. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

syringe and dosing needle gavage/feed

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 male and 3 female rats

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All three males and all three females survived the 2000 mg/kg oral dose.

Clinical signs:

other: None

Other findings:

Necropsy results were normal.
Instances of dyspnea, noted in one animal, were the only pysical signs noted during the study.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US OSHA

Conclusions:

This substance is considered to be in Acute Toxic Class 0. The LD50 is greater than 2000 mg/kg.

Executive summary:

This substance is considered to be in Acute Toxic Class 0. The LD50 is greater than 2000 mg/kg.