Registration Dossier

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
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:
1967
Report date:
1967

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate
EC Number:
213-551-9
EC Name:
Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate
Cas Number:
976-56-7
Molecular formula:
C19H33O4P
IUPAC Name:
diethyl [(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]phosphonate

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult animals
- Weight at study initiation: average body weight of about 3 kg
- Housing: single housing
- Diet: standard rabbit food ad libitum
- Water: ad libitum
- Acclimation period: 7 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
50% aqueous suspension
Details on dermal exposure:
TEST SITE
- Area of exposure: about 10 % of the total body surface area
- Type of wrap if used: impervious plastic sheeting
- Preparation of test site: The backs of the rabbits were shaved free of hair with electric clippers, the shaved area constituting about 10 % of the total body surface-area. Additionally, epidermal abrasions were made every 2 or 3 centimeters longitudinally over the area of exposure on one female and one male animal.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: after removing of the wrap

TEST MATERIAL
- Amount applied: 5 g/ kg bw
- Concentration: 50 % (w/v) aqueous suspension
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: before application, on day 8 and on day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
no adverse effect observed
Gross pathology:
no findings

Any other information on results incl. tables

Scarified and unscarified rabbits gave indistinguishable results.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met