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:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2-Hydroxy-5-nonyl(branched)-benzaldehyde oxime
EC Number:
605-717-8
Cas Number:
174333-80-3
Molecular formula:
C16H25NO2
IUPAC Name:
2-Hydroxy-5-nonyl(branched)-benzaldehyde oxime
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Lix 860 N I
- Physical state: brown viscous liqid
- Analytical purity: ca. 90% (ca. 84 % AS+ ca. 5 % Nonylphenol + ca. 1 % Etheraldehyde) based on similar test material
- Solvent: ca. 10 % Kerosene based on similar test material.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry
- Weight at study initiation: 2-3 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Clip the application site (a band around the trunk) free of hair. Abrade the skin of both groups by making longitudinal abrasions every 2-3 cm such as to penetrate the stratum corneum but not the dermis. Apply the test substance uniformly to at least 10% of the body surface (240 cm2 ) of each animal. Apply the material under 2-ply gauze then wrap the trunk of each animal in plastic sheeting to retard evaporation and keep the test substance in contact with the skin. 24 hours after application, remove the wrappings and wipe the skin to remove any remaining test substance.
Duration of exposure:
24 h
Doses:
2 g/kg b.w.
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment
Details on study design:
Observe the animals for at least 14 days or until signs of reversible toxicity subside whichever occurs later. Observations shall be made frequently during the day of dosing and twice daily thereafter (once in the morning and again in the late afternoon). Record the nature, onset, severity, and duration of each toxic and pharmacologic sign, such as abnormal or unusual cardiovascular, respiratory, excretory, behavioral, or other activity, as well as signs indicating an adverse effect on the centrai nervous system (paralysis, lack of coordination, staggering); pupillary reaction; and time of
death. Also, record the weight of each animal on the day·of dosing, weekly thereafter and at death.
All animals living at the termination of the observation period shall be sacrificed.
All test animals shall be subjected to a complete gross necropsy following death. All abnormalities shall be recorded. In addition, all treated skin tissue shall be subjec to histological examination.
Statistics:
N/A

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One of ten rabbits was found dead on day 4.
Clinical signs:
Dead rabbit showed dehydration before death.
All other rabbits showed same signs as the control rabbits.
Body weight:
Body weights stagnated or increased over observation period of 14 days.
Gross pathology:
no findings except in dead rabbit (friable and pale liver appearing mottled; dehydrated and very dark peritoneum: abdomial skin ahrd, cracked with sognificant erythema seen)
Other findings:
none stated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a study according to a FDA guideline, which is equivalent to OECD guideline 423, the acute dermal LD50 to rabbits of the test substance was determined to exceed 2000mg/kg body weight.
Executive summary:

A limit test with a dose of 2000 mg/kg bodyweight was performed. The test substance was applied unchanged under occlusive conditions for 24h to the skin of ten New Zealand White rabbits of both sexes, which were observed for 14 days post application. One rabbit was found dead on day 4. Body weights stagnated or increased, while no pathological abnormalities were present in all rabbits, except the dead rabbit.

Thus, the rabbit acute dermal toxicity LD50 of the test substance exceeded 2000mg/kg bodyweight.