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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:
from 23 Nov 1999 to 7 Dec 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP. The test material was similar to the registered substance but contained a higher proportion of an S3 isomer. The original study and the read-across are considered to be reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)IGS BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Labs, Raleigh, NC, USA

- Age at study initiation: 8 wk (m), 9 wk (f)

- Weight at study initiation: 293-315 g (m), 241-265 g (f)

- Diet (e.g. ad libitum): standard diet, ad libitum

- Water (e.g. ad libitum): drinking water, ad libitum

- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 71.4-72.1 deg F

- Humidity (%): 33.7-44.6

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

IN-LIFE DATES: From: 1999-11-24 To: 1999-12-07

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- % coverage: 18-23

- Type of wrap if used: gauze binder with non-irritating tape


REMOVAL OF TEST SUBSTANCE

- Washing (if done): wiped with moistened paper towel

- Time after start of exposure: 24 h


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 1.94 ml/kg bw (1.03 g/ml)


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 (in dose groups)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: observations mortality twice daily, clinical changes daily, body weight days 0, 7, 14

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight
Statistics:
None given - limit test

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
No treatment-related effects.
Body weight:
Weight gain (males and females)
Gross pathology:
No treatment-related effects detected.
Other findings:

- Other observations: eschar (scabbing or sloughing) in 3/10, resolved by day 10; desquamation (shedding of skin) in 6/10, resolved by day 14. No erythema or oedema.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity

 Dose
(mg/kg bw)

Mortality (# dead/total)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

2000

0/5

0/5

0/10

No systemic toxicity only local effects reported  

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
From a reliable study conducted in compliance with the standard guideline and in accordance with GLP, no mortality or systemic effects were seen at 2000 mg/kg bw. The test substance was similar to the registered substance but contained a higher proportion of an S3 isomer.