Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1988-03-16 to 1988-03-0-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: males: 281 +/- 5 g; females: 221 +/- 6 g
- Fasting period before study: no
- Housing: polypropylene cages (one animal per cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 7 cm
- % coverage: approximately 10% of body surface
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): n.a.
- Constant volume or concentration used: n.a.
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): water
- Concentration (if solution): n.a.
- Lot/batch no. (if required): n.a.
- Purity: n.a.
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight (limit dose)
No. of animals per sex per dose:
5 male; 5 female
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
n.a.

Results and discussion

Preliminary study:
n.a.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality througout study period
Clinical signs:
no clinical signs throughout study period
Body weight:
not affected
Gross pathology:
no abnormalities
Other findings:
- Organ weights: no data
- Histopathology: not performed
- Potential target organs: no target identified
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
Conclusions:
The LD50 of the test material was greater 2000 mg/kg body weight in rats. According to the criteria laid down in CLP (Reg 1272/2008/EC) and directive 67/548/EEC, the test material is not classified for acute dermal toxicity.
Executive summary:

The acute dermal toxicity of the test material (dihydrogenated tallowalkyldimethyl ammonium chloride, purity approximately 97%) was investigated in rats according to OECD Test Guideline 402 in compliance with the principles of GLP. The test substance was applied as an aqueous suspension to the shaved skin of 5 male and 5 female animals at a dose level of 2000 mg/kg body weight (limit dose) under occlusive conditions. Mortality, general behaviour, clinical signs and body weight development were recorded daily for an observation period of 14 days. A necropsy was performed on each animal sacrificed at the end of the study. There was no mortality throughout the study period at the dose level of 2000 mg/kg body weight. General behaviour and bodyweight of the animals were not influenced by the treatment. Clinical signs of significance were not observed. Skin dryness was noted after the removal of the dressing up to day 6 in all animals. Additional signs of skin irritation were not observed. The macroscopic examination of the main organs did not reveal abnormalities in any of the animals sacrificed at the end of the observation period. Based on the study results, the median lethal dose (LD50) of the test material when administered dermally to rats is greater than 2000 mg/kg body weight. Additionally, at this dose level the test material did not induce any signs of toxicity.