Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
February - March 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This is a GLP guideline study and is used in read-across from Alchisor CAL 123 (see 'Read Across Justification Document'). The study merits a Klimisch 1 rating; Klimisch 2 when used for read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Humidity was outside protocol range but did not affect study outcome.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Alkenes, C11-12, hydroformylation products, distn. residues, Alchisor CAL (Commercial Name)
- Substance type: pure active substance
- Physical state: colourless liquid
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Texas Animal Specialities, Humble, TX, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 300-336 g (males); 184-200 g (females)
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages
- Diet (e.g. ad libitum): PMI Feeds Inc. Formulab #5008, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 25 - 61 (humidity was outside protocol range)
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2010-02-10 To: 2010-03-04

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 10
- Type of wrap if used: The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritation adhesive tape. The trunk of each animal was then wrapped with vet wrap that was secured in place with non-irritation adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with room temperature tap water and a clean cloth to remove as much residual test substance as possible
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.38 mL/kg
- Constant volume used: no, an individual dose was calculated for each animal based on its day 0 body weight just before exposure
- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
2020 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded just prior to dosing and on days 7 and 14. Observations for evidence of dermal irritation were made at approx. 60 minutes after removal of wrappings and on days 4, 7, 11 and 14.
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 020 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
no clinical signs of toxicity or dermal irritation were recorded
Body weight:
animals exhibited weekly weight gain during the study
Gross pathology:
no observable abnormalities were detected
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 was greater than 2020 mg/kg bodyweight in male and female rats.
Executive summary:

The test substance, Alkenes, C11 -12, hydroformylation products, distn. Residues (CAS No. 90622 -27 -8), was evaluated for its dermal toxicity potential and relative skin irritancy when a single undiluted dose of 2020 mg/kg, was applied to the intact skin of albino rats. No mortality occurred during the study. There were no clinical signs of toxicity of signs of dermal irritation at any time throughout the study. Animals exhibited weekly weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The estimated LD50, as indicated by the data, was determined to be greater than 2020 mg/kg.