Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
The relative humidity was once higher than the top limit mentioned in the guidelines. No other deviations fromt he protocol occurred during this study.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C10-16
EC Number:
267-019-6
EC Name:
Alcohols, C10-16
Cas Number:
67762-41-8
IUPAC Name:
tetradecan-1-ol
Details on test material:
- Name of test material (as cited in study report): Safol(TM) 23 Alcohol C10-16 alcohols Type B (also known as Compound 33A). Equivalent to Alcohols, C12-13-branched and linear (CAS 740817-83-8).

- Physical state: clear, transparent liquid

- Storage condition of test material: at ambient temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River WIga, Germany
- Age at study initiation: 5-6 weeks
- Housing: stainless steel cages filled with wire screen floor and front, 5 animals/cage, except during exposure individually housed
- Diet: standard laboratory rodent diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 13

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%):52-75
- Air changes (per hr):ca.10
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 15.04.1998 To: 12.05.1998

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: undiluted
Details on dermal exposure:
TEST SITE
- Area of exposure:  back and flank, at least 4cm x 5cm
- % coverage: 10
- Type of wrap if used: plastic foil attached by adhesive tape and wrapped with  impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residue removed with water.
- Time after start of exposure: 24 hours

Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded immediately before dosing and of the surviving animals on days 3, 7 and 14 of the study. Observations were made within 1 hour and within 4 hours after dosing and subsequently at least once daily throughout an observation period of 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: All visible reactions to treatment were recorded, including type, severiuty, onset and duration. The animals were killed with carbon dioxide and the abdomen and thorax of each animal opened and examined for gross pathological changes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived the exposure period and subsequent 14 day  observation period.
Clinical signs:
None observed. All animals gained in body weight over the  14 day observation period following a slight dip in weight at day 3.
Body weight:
All males and females showed a minor dip in body weight on day 3 of the study.
Gross pathology:
Unremarkable.
Other findings:
APPLICATION SITE: No signs of irritation were observed.
POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The rat dermal LD50 (24 hour occluded) was >2000 mg/kg. There was no irritation at the application site and no clinical signs of toxicity. Necropsy findings were unremarkable.