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Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: cf. 16 CFR 1500.40
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
5-(C11-C12 alkyl, branched)-2-hydroxy-benzaldehyde oxime
EC Number:
Molecular formula:
C18H29NO2 - C19H31NO2 (main constituents)
5-(C11-C12 alkyl, branched)-2-hydroxy-benzaldehyde oxime
Details on test material:
- Name of test material (as cited in study report): Dodecyisalicylaldoxime
- Physical state: liquid
- Analytical purity: no data

Test animals

New Zealand White
Details on test animals or test system and environmental conditions:
Thirty adult New Zealand white rabbits (15 males and 15 females), purchased from an approved USDA supplier weighing between 2.64 -4.16 kg were used in this study. All animals were maintained and examined with respect to their general health and suitability as test animals. The rabbits were then housed individually in wiremesh cages and maintained on Laboratory Rabbit Formula. Food and water were offered ad libitum.

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
No more than 24 hours prior to the dermal applications the backs of each rabbit were clipped free of hair with a commercial electric clipper with a No. 40 blade over an area constituting about 30 percent of the total body surface. The animals were then returned to their cages.
On the day of testing and just prior to the application of the test material, abrasion of the skin was performed on the exposure sites of 2 males and one female per each of 5 groups. The skins of the remaining male and two females per group were left intact. Abrasions were made with the point of a 23 gauge, disposable hypodermal needle. The abrasions were minor incisions through the stratum corneum and were not sufficiently deep enough to disturb the derma or to produce bleeding.
The animals (30) were equally assigned to five test groups with 3 males and 3 females per group. Skin applications were made on the intact skin of 1 male and 2 females per group, and on the abraded skin of the remaining animals per group.
The test material at levels of 8.41, 10.0, 12.60, 15.87, 20.00 g per kg was introduced under a square gauze patch of each of the four animals. A layer of plastic wrap (Grand Union), secured with masking tape vas applied to the torso of the animals to prevent evaporation of the applied material. This layer was then covered with a protective cloth and AceR bandage binder. When securing the wraps with masking tape, care was taken to avoid contact with the animals's skin.
Duration of exposure:
24 h
8.41, 10.0, 12.60, 15.87, 20.00 g/kg
No. of animals per sex per dose:
Control animals:
other: untreated skin of the same animals
Details on study design:
The test material remained in contact with the skin for 24 hours. Behavioral reactions were observed and recorded during the contact period, after which the plastic sheeting was removed from each test rabbit. The exposure sites were examined for local reactions-and the animale returned to their cages.
Observations for mortality, local reactions, and behavioral abnormalities were continued for a total of 14 days following the skin applications. Initial, 7 day and 14 day body weights were recorded.
All animals that died, or were sacrificed moribund during the study were subjected to an autopsy, and all significant gross pathologic alterations were recorded.
At the end of the observation period all data vere collected and the acute dermal LD was calculated by pertinent statistical methods or estimated when mortality data did not permit statistical evaluation.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 8 410 - < 10 000 mg/kg bw
Based on:
test mat.
at 8410 mg/kg 0/6 animals died; at 10000 mg/kg 3/6 animals died, at 12600 mg/kg 1/6 animals died, at 15870 mg/kg 2/6 animals died and at 20000 mg/kg 3/6 animals died
Clinical signs:
8410 mg/kg: Ataxia, Decreased activity, Back -red and swollen; pulling out matted fur (1M & 2F), Back -burned (2M & 3F), Few feces, Pulling dead skin off of back (2M & 3F), Back dry (2M & 1F), No feces (2M), soft stools (3F), Diarrhea (1M & 1F), Mouth and nose red in color (1M), Animals appeared to have lost appetite beginning day 4.
10000 mg/kg: Back burned, Decreased activity, Ataxia, No feces, Very few feces (1M & 2F), Diarrhea (1M), Pulled mont of dead skin off back (1F), From day 5 all animals were observed to be pulling out matted fur. Throughout duration of study all animals appear to have extremely decreased appetites. Gasping (1F), Deathe (2M & 1F).
12600 mg/kg: Back burned, Mucus-like substnace ln fecal tray (1F), Decreased activity, Ataxia, Very few feces (3M & 2F), Mouth area very red in color (1M), Pulled most of dead skin off of back (1M), Appears net te be able te lift head up (1F), Diarrhea (1M), Mouth area and underside
of stomach appeared to be burned (1F). Frem day 5 all animale were observed te be pulling matted fur from bodies.
Throughout duration of study all animals appeared to have extemely decreased appetites. Deaths (1F).

At 15870 and 20000 mg/kg: not reported
Body weight:
8410 mg/kg: mean males: day 0: 3,31 kg; day 7: 2,78 kg; day 14: 2.77 kg and mean females: day 0: 3,65 kg; day 7: 3,13 kg; day 14: 3,09 kg
10000 mg/kg: mean males: day 0: 3,30 kg; day 7: 2,60 kg; day 14: 2.59 kg and mean females: day 0: 3,62 kg; day 7: 2,95 kg; day 14: 2,72 kg
12600 mg/kg: mean males: day 0: 3,09 kg; day 7: 2,48 kg; day 14: 2.28 kg and mean females: day 0: 2,98 kg; day 7: 2,49 kg; day 14: 2,53 kg
15870 mg/kg: mean males: day 0: 3,28 kg; day 7: 2,37 kg; day 14: 2.08 kg and mean females: day 0: 3,37 kg; day 7: 2,63 kg; day 14: 2,44 kg
20000mg/kg: mean males: day 0: 2,99 kg; day 7: 2,24 kg; day 14: 2.30 kg and mean females: day 0: 3,22 kg; day 7: 2,46 kg; day 14: 1,96 kg
Gross pathology:
8410 mg/kg: none
10000 mg/kg: Lungs: dark and mottled (2M); almost white in appearance (1F). Liver: dark with blanched areas (2M); pale, granular and mottled (1F). Spleen: dark (2M & 1F). Kidneys: pale (2M)j pale and vascularized (1F). Stomach and Large Intestine: air filled (2M & IF). Gall Bladder: 1) appears very enlarged, measured to be approx.mately 3.5 cm wide and 5 cm long (1M). 2) appears enlarged and leached onto stomach and livery measured to be approximately 2.5 cm wide and 4 cm long(1M); appears enlarged an leached onto stomach and liver (1F). Ail Organs: appear very dry in texture (2M).
12600 mg/kg: Organs: appeared dry and sticky (IF). Lunges very dark (1F). Livert dark with blanched areas (1F). Spleens very dark (1F). Gall Bladder: appears very enlarged (1F). Kidneys: pale with little red spots (1F). Large Intestines and Stomach: filled with hard material (1F).

At 15870 and 20000 mg/kg: not reported
Other findings:

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Migrated information Criteria used for interpretation of results: EU
The dermal LD50 in rabbits is greater than 8410 mg/kg and smaller than 10000 mg/kg.
Executive summary:

An inconsistent death pattern was observed in the original four doses (10.0, 12.60, 15.87 and 20.0 g/kg) of the LD50 study. An additional level was administered at 8.41 g/kg. No deaths were observed at this dose level.