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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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: Meets generally accepted scientific standards, well documented and acceptable for assessment. Combined study report, hence some detail issues.

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 402 (Acute Dermal 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: 208-224 g (males) and 135-155 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: PRG, Labsure Animal Foods, Dorset ad libitum by means of a top loading food hopper (except during the 24 hours after dosing)
- 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

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The day before dosing (day zero) approximately 60 % of the dorsal hair of all animals was closely shorn with fine electric clippers. Immediately before application of the test material, the skin was visually inspected to ensure that all micro-abrasions of the stratum corneum had healed. The calculated dose was applied to the shorn skin at room temperature by syringe, the dose being altered by varying the volume dispensed from the syringe. The test material was covered with a piece of aluminium foil lined with gauze and the foil held in place by a double overwrap of waterproof adhesive tape.

Duration of exposure:
24 h
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 individually earmarked. The animals were weighed on the day of dosing (day 1). The rats were individually housed for 24 hours after dosing, with food withheld but water available ad libitum. At the end of the 24 h exposure period, the tape and foil were carefully removed and the skin washed with warm dilute detergent solution and then dried. The animals were then returned to group housing. The animals were observed for signs of toxicity for 14 days after dosing. Observations were recorded up to three times a day during the first three days and daily thereafter. 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.
Remarks on result:
other: maximum dose that could be applied
Mortality:
None of the rats died
Clinical signs:
Inflamation of the treated site (see Tables 1 and 2, attached)
Body weight:
All rats gained weight relative to their day 1 bodyweight by the end of the 14 day observation period (see Tables 1 and 2, attached)

Applicant's summary and conclusion

Conclusions:
The acute percutaneous LD50 of the undiluted test substance was greater than 2000 mg/kg, the maximum dose that could be applied.