Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(only limited information on test procedure and test material identity are given, and no test material purity is stated in the study report)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Silane 44-42 (organofunctional), Dynasylan 1189
- Physical state: yellow liquid
- Lot/batch No.: 09989

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Fasting period before study: none
- Diet: appropriate diet ad libitum (not further specified)
- Water: ad libitum (not further specified)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: impervious sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess fluid was removed to prevent ingestion (not further specified)
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2, 4, 8, and 16 mL/kg bw, equivalent to 1900, 3800, 7600, and 15200 mg/kg bw (calculated based on a density of 0.95 g/cm³)
No. of animals per sex per dose:
4 animals (not further specified)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin irritation
Statistics:
The LD50 along with the 95% confidence limits was calculated by the moving average method based on a 14 day observation period.

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
15 200 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 187.5 - <= 193 800
Remarks on result:
other: (equivalent to 16.0 ml/kg bw (95% CL 1.25 -204 ml/kg bw); calculated based on a density of 0.95 g/cm³)
Sex:
not specified
Dose descriptor:
LD0
Effect level:
1 900 mg/kg bw
Based on:
test mat.
Remarks on result:
other: (equivalent to 2.0 ml/kg bw; calculated based on a density of 0.95 g/cm³)
Mortality:
- 16 ml/kg bw: 2/4 (both deaths occured on day 3)
- 8 ml/kg bw: 1/4 (animal died on day 11 post-dosing); repeated for confirmatory purpose: deaths 2/4 (animals died on days 2 and 3)
- 4 ml/kg bw: 1/4 (animal died on day 2 post-dosing)
- 2 ml/kg bw: 0/4
Clinical signs:
- 16 ml/kg bw: Erythema, oedema, necrosis, ecchymosis, fissuring, desquamation at 14 days; Prostrate at 1 day
- 8 ml/kg bw: Erythema, oedema, ecchymosis, scabs at 14 days; repeated for confirmatory purpose: Oedema, necrosis at 24 h, scabs on survivors at 14 days; Prostrate at 1 day
- 4 ml/kg bw: Oedema, necrosis, scabs at 14 days, one prostate at 24 h
- 2 ml/kg bw: Ecchymosis, oedema, necrosis
Body weight:
Mean body weight changes seen throughout the study period were:
- 16 ml/kg bw: -108 g (-397 and 182 g)
- 8 ml/kg bw: 5 g (-268 to 150 g); repeated for confirmatory purpose: 19 g (-130 to 168 g)
- 4 ml/kg bw: 26 g (-281 to 223 g)
- 2 ml/kg bw: 109 g (-13 to 208 g)
No further details are given in the study report.
Gross pathology:
In victims, the lungs were red, the livers mottled bright red and tan, the kidneys were found to be mottled tan and red, the spleens appeared dark, the stomacs were injected or opaque.
In survivors, nothing remarkable was observed.

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:
The test item was tested for acute dermal toxicity according to a test protocol that is comparable to the appropriate OECD test guideline, but without GLP compliance. The test material was occlusively administered to 4 rabbits each dose group. The LD50 was determined to be 15200 mg/kg bw. The predominant clinical signs detected were signs of irritation/corrosion, such as erythema, oedema, and necrosis. No deaths occured at 1900 mg/kg bw, but still signs of skin irritation were noted. Based on this data, classification for acute dermal toxicity according to EC/1272/2008 is not warranted.