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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
Study period:
1986-10-06 to 1987-01-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study in combined format so some detail missing. However, meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): [CAS Number 171171-80-5]
- Physical state: Dark brown viscous liquid
- Lot/batch No.: XSA 053J
- Storage condition of test material: In the dark at ambient temperature
- Stability under test conditions: Infra-red spectra taken on 14 August 1986 and 18 December 1986 showed no differences and the substance was judged to have been stable for the duration of the study

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 185-196 g (males) and 129-135 g (females)
- Fasting period before study: overnight (18 h)
- Housing: On arrival, animals were housed in single sex groups of up to 12 in a cage with each cage measuring 56 cm x 38 cm x 18 cm. The animals were quarantined in non-barried animal rooms with access restricted to essential personnel. Prior to experimentation, the animals were rehoused (as single sex groups of four) in cages with stainless steel wire-mesh floors and tops; each cage measuring 38 cm x 25 cm x 18 cm. The cages were mounted in five rows of four on both sides of a double-sided rack (a total of 40 cages). Paper-lined trays for excreta were placed beneath each cage.
- Diet: PRD, Labsure Animal Foods, Dorset ad libitum by means of a top loading food hopper
- Water: Filtered but untreated water from the public supply ad libitum by means of an automatic valve-regulated drinking line
- Acclimation period: = 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 degrees Centigrade
- Photoperiod: Automatically controlled cycle of light (06:00 to 18:00) and dark (18:00 to 06:00)

Administration / exposure

Route of administration:
other: intraoesophageal intubation
Vehicle:
unchanged (no vehicle)
Remarks:
at room temperature
Details on oral exposure:
Dosing was by intraoesophageal intubation using a ballpoint needle fitted to a syringe, the dose being altered by varying the volume dispensed from the syringe.
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five males and five females
Control animals:
no
Details on study design:
At least two days before dosing, the rats to be used were housed in groups of two or three animals of the same sex per cage and each animal was individually earmarked. All animals were weighed on the day of dosing after fasting overnight. After dosing the animals were given food and water ad libitum and observed for clinical signs over the following 14 days. Observations were recorded up to three times a day during the first three days and daily thereafter. The initial (day 1), day 7 and day 14 body weights were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the rats died.
Clinical signs:
Soft faces on the day of dosing
Body weight:
All rats gained weight relative to their day 1 bodyweight by the end of the 14 day observation period

Any other information on results incl. tables

Body weights and clinical signs recorded in male and female rats during the determination of the acute oral LD50 of [CAS Number 171171 -80 -5] are presented in Table 1 (attached).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of undiluted [CAS Number 171171-80-5] was > 2000 mg/kg in the rat.