Reaction mass of bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Aug. 6, 1981 to Sep. 28, 1981

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:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

-No individual data; justification for choice of vehicle was not provided

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl 1,2,2,6,6-pentamethylpiperidin-4-yl decanedioate; bis(1,2,2,6,6-pentamethylpiperidin-4-yl) decanedioate

EC Number:

915-687-0

Cas Number:

1065336-91-5

Molecular formula:

unspecified

IUPAC Name:

1-methyl 1,2,2,6,6-pentamethylpiperidin-4-yl decanedioate; bis(1,2,2,6,6-pentamethylpiperidin-4-yl) decanedioate

Details on test material:

- Physical state: Liquid

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Raised on the premises (CIBA-GEIGY Limited, Experimental Toxicology Sisseln GU 2.1)
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 200-214 g for males and 176-181 g for females
- Fasting period before study: Animals fasted overnight before orally treated
- Housing: Housed in groups of 5 in Macrolon cages (type 3)
- Diet: NAFAG No. 890, NAFAG, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: A minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: polyethylene glycol 400

Details on oral exposure:

VEHICLE:
Polyethyleneglycol 400 (PEG 400), Fluka AG, Buchs, SG
- Amount of vehicle (if gavage): 10 and 20 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

DOSAGE PREPARATION:
The test substance was diluted to achieve a concentration suitable for the dose levels selected for this test.

Doses:

1000, 2500 and 5000 mg/kg body weight.

No. of animals per sex per dose:

10 animals per sex per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded immediately prior to dosing and at 7 and 14 days. Physical condition and rate of deaths were monitored throughout the whole observation period.
- Necropsy of survivors performed: Yes, all animals were submitted to a necropsy, whenever they died, survivors at the end of the observation period.

Toxicity rating was evaluated according to company standards (see Table 1).

Statistics:

The LD50, including the 95% confidence limits were calculated by the logit model.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 230 mg/kg bw

95% CL:

2 615 - 4 247

Mortality:

For one sex (not further specified), no deaths were reported in the 1,000 and 2,500 mg/kg groups, nine deaths were reported in the 5,000 mg/kg group: 1 animal died 3 hours after treatment; 4 animals died 24 hours after treatment; 3 animals died 2 days after treatment; 1 animal died 3 days after treatment.

In the other sex (not specified), 2 deaths were reported in the 2,500 mg/kg group and 10 deaths were reported in 5,000 mg/kg group (sex not specified). In the 2,500 mg/kg group, 2 animals died 2 days after treatment. In the 5,000 mg/kg group, 1 animal died 3 hours after treatment; 2 animals died 5 hours after treatment; 6 animals died 24 hours after treatment; 1 animal died 2 days after treatment.

Clinical signs:

other: The surviving animals recovered within 5-9 days. In the 1,000 mg/kg dose group: slight sedation was observed at 1, 2, 3, 5, and 24 hours; slight dyspnoea was observed at 1, 2, 3, 5, and 24 hours and at Days 2 to 8; slight ruffled fur was observed at 1,

Gross pathology:

No compound related gross organ changes were observed.

Other findings:

Not applicable.

Any other information on results incl. tables

Table 2. Body weights in grams and standard deviation

Dose (mg/kg)	Males			Females
	Day 1	Day 7	Day 14	Day 1	Day 7	Day 14
1,000	200 ± 9.1	246 ± 9.9	289 ± 7.6	180 ± 5.3	197 ± 6.7	216 ± 6.6
2,500	214 ± 6.7	252 ± 7.3	290 ± 6.9	176 ± 3.8	200 ± 5.2	219 ± 6.0
5,000	207 ± 6.7	-	-	181 ± 2.9	-	-

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test item in rats of both sexes observed over a period of 14 days is 3230 (2615-4247) mg/kg bw.