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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
Study period:
October to November 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: missing test substance characterisation, reduced observation period of 7 days, no information on clinical observations and body weights
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: HAZARDOUS SUBSTANCES, Part 191, Section 11, FDA, Washington 1965
GLP compliance:
no
Test type:
other: Rabbits were exposed to test substance for 24 hours on intact and scarified skin. The treatment was followed by a 7-day observation period. Skin reactions, behaviour, general condition, food and water consumption and body weight gain were recorded.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Octyl-1-dodecanol
- Substance type: pure active compound
- Physical state: liquid
- Lot/batch No.: 03508
- Expiration date of the lot/batch: January 1, 2011
- Storage condition of test material: room temperature, protected from moisture and light

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: laboratory breed
- Age at study initiation: not mentioned
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Altromin 2023, ad libitum, supplied by Altromin GmbH, Lage, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 60 ± 3
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 15 x 16 cm on the back of the animals, 3 animals per sex were treated on intact skin, 3 animals per sex were treated on abraded skin
- % coverage: 10
- Type of wrap if used: not wrapped


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30°C)
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.3-2.8 ml and 4.6-5.6 ml
- Constant volume or concentration used: no
Duration of exposure:
24 hours
Doses:
1 and 2 mL/kg b.w.
No. of animals per sex per dose:
3 with intact skin, 3 with scarified skin
Control animals:
other: control group (3 animals per sex with intact skin, 3 animals per sex with scarified skin) exposed with methylhydroxy ethyl Cellulose Gel 300 P, 1% in water
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: skin effects (erythema, edema) were recorded 5, 15, 30 min, 1, 2, 4, 24, 48, 72, 96, 120, 144 and 168 hours after removal of the test substance. General behaviour, food and water intake and body weight were recorded daily.
- Necropsy of survivors performed: no
- Other examinations performed: none

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Mortality:
no mortality occured during the course of the study
Clinical signs:
only slight skin irritation noted
Body weight:
no data recorded
Gross pathology:
not performed
Other findings:
Necrosis and rhagades were not observed, growth of hair was not affected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
2-Octyldodecan-1-ol is practically nontoxic after dermal administration to rabbits.