Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

- Size of the treatment area not indicated - Low number of animals (3/sex instead of 5) - No information on body weight gain

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate

EC Number:

258-207-9

EC Name:

Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate

Cas Number:

52829-07-9

Molecular formula:

C28H52N2O4

IUPAC Name:

bis(2,2,6,6-tetramethylpiperidin-4-yl) sebacate

Specific details on test material used for the study:

The formulation is 50% test substance in 2% CMC (aqueous susp. assumed, but not specifically stated in the report)

Test animals

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy breeding unit
- Age at study initiation: not indicated
- Weight at study initiation: 180-200 g
- Housing: individually in Macrolon cages (type 2)
- Diet: ad libitum rat food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Type of coverage:

occlusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2%

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: not indicated (shaved area 60 cm²)
- Type of wrap if used: occlusive dressing which was fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not indicated
- Concentration (if solution): 50% formulation

Duration of exposure:

24 hours

Doses:

2150 and 3170 mg/kg bw
no higher concentrations were possible

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 170 mg/kg bw

Mortality:

- Number of deaths at each dose: no deaths occurred
- Time of death: not applicable

Clinical signs:

other: Dyspnoea, exophthalmus, ruffled fur and hunched posture. Animals recovered within 13 days.

Gross pathology:

No test substance related gross changes.

Other findings:

SEX-SPECIFIC DIFFERENCES: None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was determined to be higher than 3170 mg/kg bw