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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1996/03/06-1996/04/16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP. The study is a read across from hexadecan-1-ol (CAS 36653-82-4).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
other: LD50
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River (UK) Ltd., Margate, Kent, UK.

- Age at study initiation: 5-8 weeks

- Weight at study initiation: Males 135-145g, females 127-137g.

- Fasting period before study: Overnight, immediately before dosing.

- Housing: Housed in groups of up to five by sex in solid floor polypropylene cages furnished in woodflakes.

- Diet: Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK (ad libitum)

- Water: Mains drinking water (ad libitum)

- Acclimation period: Minimum of five days.


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 19-22C

- Humidity (%): 39-60%

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: arachis oil
Details on oral exposure:
VEHICLE

- Amount of vehicle (if gavage): 10 ml/kg at a concentration of 200 mg/ml in arachis oil.

- Lot/batch no. (if required): 2439


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.


DOSAGE PREPARATION (if unusual): All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe.


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A range finding study was carried out prior to dosing, using 1 male and 1 female rat which were administered 200 mg/kg of test substance at the concentration of 200 mg/ml in the volume of 10 ml/kg. The animals were observed for deaths and overt signs of toxicity 30 min, 1h, 2h and 4 hrs after dosing and subsequently for five days.
Doses:
2000 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Individual body weights were recorded prior to dosing on dayy 0 and on days 7 and 14. The animals were observed for deaths or overt signs of toxicity at 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Necropsied animals were examined externally and their abdominal and thoracic cavities opened for the examination of major organs. No tissues were retained. All animals were subject to gross pathological examination at the end of the observation period.
Statistics:
No statistical analysis of the results was carried out in this study.

Results and discussion

Preliminary study:
A range finding study was performed to establish a dosing regime as follows: 2000 mg/kg at the concentration of 200 mg/ml in dose volume of 10 ml/kg to 1 male and 1 female rat. The rats were observed for overt signs of toxicity at 30min, 1h,2h and 4hrs after dosing subsequently once daily for five days.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
No clinical signs of systemic toxicity. 
Body weight:
All animals showed the expected body weight gain over the observation period.
Gross pathology:
Necropsy findings were unremarkable
Other findings:
POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None observed.

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 Kalcol 6098 is >2000 mg/kg. At this dose level there were no signs of toxicity. The result is a read across from hexadecan-1-ol (CAS 36653-82-4).