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Toxicological information

Acute Toxicity: oral

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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: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hexaoxatricosane (TP-90B Rubber Chemical)
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy S.r.l., San Pietro al Natisone, Italy
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 176-200 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:
550, 2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg: 5 females
330 mg/kg: 1 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Immediately following dosing, 30 minutes, 2 hours, 4 hours, and daily thereafter for a total of 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
1 animal died at 2000 mg/kg bw approximately one hour after dosing.
Clinical signs:
Animal 1 exhibited convulsions approximately 5 minutes following dosing. A degree of recovery soon occurred although the animal was lethargic 30 minutes after dosing and remained so throughout the first day. In addition, lacrimation was noted approximately 4 hours after administration of the test item. Recovery had occurred within 24 hours.
Animal 2 exhibited convulsions, lacrimation, and salivation approximately 30 minutes after dosing. Death had occurred within approximately one hour.
Animal 3 exhibited lethargy on Day 1. Reduced activity and hunched posture were then noted on days 2 and 3. Recovery occurred by day 4.
Animal 4 was unconscious within approximately 30 minutes of dosing. Some recovery was apparent within 24 hours of dosing, when piloerection was noted. Full recovery had occurred within 48 hours.
Animal 5 appeared moribund within approximately 30 minutes of dosing, remaining so for the remainder of the day. It was cold to the touch and exhibited a hunched posture on days 2 and 3. Recovery had occurred within 72 hours.

At 550 mg/kg: Convulsions were apparent within approximately 6 minutes of dosing. A degree of recovery soon occurred with the animal remaining lethargic from approximately 11 minutes after dosing and continuing for the remainder of the day. Recovery had occurred within 24 hours.
Gross pathology:
No abnormalities were observed in any animal at the necropsy examination performed at the end of the observation period or in the early decedent animal.

Applicant's summary and conclusion