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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP. The original study was reliability 1. Read across to the registered substance is considered scientifically justified and reliabiltiy 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

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:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C10-16
EC Number:
267-019-6
EC Name:
Alcohols, C10-16
Cas Number:
67762-41-8
IUPAC Name:
tetradecan-1-ol
Details on test material:
- Name of test material (as cited in study report): Safol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A). Equivalent to Alcohols, C12-13-branched and linear (CAS 740817-83-8).

- Physical state: clear, transparent liquid

- Storage condition of test material: at ambient temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Wiga, Germany
- Age at study initiation: 5-6 weeks
- Weight at study initiation: mean bodyweight males 215g, females 151g
- Fasting period before study: overnight
- Housing: a maximum of 5 animals/cage, stainless steel cages fitted with wire screen floor and front
- Diet: standard leboratory rodent diet, ad libitum (except fast and 4 hours after administration of test substance)
- Water: tap water, ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 52-75
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 April 1998 To: 12 May 1998

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.5ml/kg bw

Doses:
2000 mg/kg
No. of animals per sex per dose:
3M, 3F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made within 1 hour and within 4 hours after dosing, and subsequently at least once daily throughout the rest of the observation period. The body weight of each animal was recorded immediately before dosing, and of the surviving animals on days 3, 7 and 14 of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were examined for external changes; the abdomen and the thorax of each animal was then opened and examined for gross pathological changes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no mortalities.
Clinical signs:
Diarrhoea was observed in 1 male and 2 females within 4  hours of dosing.  2 females showed piloerection within 1 hour of dosing  while the remaining female showed sluggishness and piloerection within 1  and 4 hours and hunching and blepharospasm within 1 hour.  During the  remainder of the 14 day observation period none of the animals showed any  clinical signs. 
Body weight:
All animals gained weight normally during the study.
Gross pathology:
Unremarkable.
Other findings:
SEX-SPECIFIC DIFFERENCES: No difference in mortality females showed more  clinical signs immediately after dosing but all normal within 24 hours.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The rat oral LD50 for Safol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A) is >2000 mg/kg. There was no target organ toxicity. Transient signs of intoxication occurred within a few hours of dosing and included diarrhoea, piloerection and lethargy. Findings at gross necropsy were unremarkable.