Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1953
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles; basic data given. Insufficient documentation of experimental methods and examination procedures.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1953
Report date:
1953

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Observation period of 7 days instead of 14 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
6,6'-di-tert-butyl-4,4'-diethyl-2,2'-methylenediphenol
EC Number:
201-814-0
EC Name:
6,6'-di-tert-butyl-4,4'-diethyl-2,2'-methylenediphenol
Cas Number:
88-24-4
Molecular formula:
C25H36O2
IUPAC Name:
2-tert-butyl-6-[(3-tert-butyl-5-ethyl-2-hydroxyphenyl)methyl]-4-ethylphenol
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: Not provided
- Fasting period before study: Not provided
- Housing: Individually
- Diet (e.g. ad libitum): Not provided
- Water (e.g. ad libitum): Not provided
- Acclimation period: Not provided

ENVIRONMENTAL CONDITIONS
Not provided


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: abdomen
- % coverage: Not provided
- Type of wrap if used: The material was spread on butcher paper which was placed against the closely shaven abdomen and held with gauze.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 18 hours

TEST MATERIAL
- For solids, paste formed: yes, in order to make a smooth paste approximately 1.0 ml of 0.5% methyl cellulose was used per gm of material.
Duration of exposure:
18 hours
Doses:
1.0, 4.0 and 8.0 gm/kg
No. of animals per sex per dose:
Three groups of 4 rabbits were used per dose level.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Not provided
- Necropsy of survivors performed: Yes
- Other examinations performed: Observations were made for dermal irritation and systemic toxicity

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities at any dosage level tested.
Clinical signs:
other: No dermal irritation was noted at the 1.0 gm/kg dosage level, whereas a mild degree of erythema developed at 4.0 and 8.0 gm/kg. Skin irritation subsided within 24 to 48 hours.
Gross pathology:
At autopsy the only significant grossly observable finding was an increase in peritoneal fluid.
Other findings:
Not provided

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of undiluted test item for albino rabbits is >8000 mg/kg bw.
Executive summary:

Groups of four albino rabbits were used to study the irritative and penetrative properties of the test item following a single application of the undiluted material at dosage levels of 1.0, 4.0 and 8.0 gm/kg body weight. In order to make a smooth paste approx. 1.0 ml of 0.5% methyl cellulose was used per gram of material. The paste was spread on butcher paper which was placed against the closely shaven abdomen and held with gauze. After an exposure of 18 hours the binders were removed and the animals bathed with water to remove the residue. The animals were observed for gross signs of dermal irritation and systemic toxicity for a period of seven days, after which they were sacrificed and gross autopsies performed. There were no mortalities at any dosage level tested. No dermal irritation was noted at the 1.0 gm/kg dosage level, whereas a mild degree of erythema developed at 4.0 and 8.0 gm/kg. Skin irritation subsided within 24 to 48 hours. The acute dermal LD50 of test item for albino rabbits is >8000 mg/kg bw.