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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:
16.09.1991 to 10.03.1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa-Crédo, FRANCE
- Age at study initiation: 6-8 wk
- Weight at study initiation: 212-259 g (variability within sex <20%)
- Fasting period before study: none specified
- Housing: 1/F1 polycarbonate cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1991-11-18 To: 1991-12-03

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: approx 10%
- Type of wrap if used: semi-occlusive (perforated adhesive band/elastic crepe bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with Codex absorbant gauze
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2007 mg/kg bw (2.23 mL/kg bw)
- Concentration (if solution): neat liquid
Duration of exposure:
24 h
Doses:
2007 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation at 0 and 15 mins, 1, 2 and 4 h, then daily until study completion at 15 days; weighting on Days 0, 8 and 15. The daily observations performed, amongst others, included changes in the fur, in the treated skin, the eyes, mucous membranes, respiratory system, circulatory system, autonomic and central nervous systems, as well as somato-motor activity and behaviour. Shivering, convulsions, salivation, diarhoea, lethargy, sleeping and coma were noted with particular attention.
- Necropsy of survivors performed: yes, on Day 15 all rats were killed and necropsied. Particular attention was paid to liver, heart, kidneys, lungs and skin of application site.
- Other: Cutaneous lesions were evaluated daily for each rat from Days 2 to 15, according to a scale equivalent to that of Draize.
Statistics:
The body weights of the animals were evaluated for each sex, calculating the mean of the values obtained, the standard deviation, the coefficient of variation which indicates the homogeneity of the data.

As no deaths were observed an LD50 could not be calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 007 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no deaths, no clinical effects
Mortality:
0/10
Clinical signs:
No effects reported.
Body weight:
No treatment-related effects reported.
Gross pathology:
No abnormal observations.
Other findings:
No local effects (erythema or oedema).

Any other information on results incl. tables

Table1. 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

2007

0/5

0/5

0/10

0/5

0/5

0/10

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In an acute dermal toxicity study conducted in compliance with OECD 402 and in accordance with GLP (reliability score 1), there were no mortality or other adverse effects observed at 2007 mg/kg bw. (24 hour exposure) (LD0 and LD50 > 2007 mg/kg bw).