Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 402: pre-GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1960
Report date:
1960
Reference Type:
publication
Title:
Acute toxicity of a homologous series of branched chain primary alcohols
Author:
Scala RA and Burtis EG
Year:
1973
Bibliographic source:
Am Ind Hyg Assoc J 34:493-499

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C9-11-iso-, C10-rich
EC Number:
271-234-0
EC Name:
Alcohols, C9-11-iso-, C10-rich
Cas Number:
68526-85-2
Molecular formula:
CnH2n+1OH (n = 9 to 11)
IUPAC Name:
Alcohols, C9-11-iso-, C10-rich
Details on test material:
- Name of test material (as cited in study report): MRD-59-13
- Physical state: clear liquid
- Analytical purity: assumed to be 100%

Test animals

Species:
rabbit
Sex:
male/female
Details on test animals or test system and environmental conditions:
No information provided.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No information provided.
Duration of exposure:
24 hours
Doses:
100, 316, 1000 or 3160 ul/kg (83.8, 264, 838, or 2648 mg/kg)
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1, 4, and 24 hours after application and once daily thereafter for 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3.16 mL/kg bw
Mortality:
None
Clinical signs:
Following removal of the gauze, the skin area showed mild to moderate erythema and edema. All symptoms subsided within 1 to 3 days. At the time of sacrifice, animals in the high dose group exhibited slight erythema, desquamation, blanched areas, necrotic areas, and a coriaceous condition.
Body weight:
None
Gross pathology:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 for isodecanol is >2648 mg/kg.
Executive summary:

The dermal toxicity and irritative properties of isodecanol were evaluated in rabbits exposed to 100, 316, 1000 or 3160 ul/kg (83.8, 264, 838, or 2648 mg/kg) via an occluded patch for 24 hours.  The animals were observed for gross effects at 1, 4, and 24 hours after application and once daily thereafter for 7 days.  All animals survived dosing. Most animals exhibited slight signs of dermal irritation with severity increasing in a dose-related manner.  Most signs of dermal irritation were resolved within 1-3 days in the two lower dose groups.  At the time of sacrifice the exposed skin area of all animals generally showed atonia and desquamation.  In addition, the animals at the 3160, ul/kg level showed blanched areas, necrotic areas, and a coriaceous condition. It is concluded that the LD50 is greater then 3160 ul/kg.