Polyamide wax

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2000-03-14 to 2000-06-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U.K.
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: 97 to 107g
- Fasting period before study: overnight prior to and for approximately hours after dosing
- Housing: in metal cages polished stainless steel grid floors
- Diet (e.g. ad libitum): standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum):water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 20.5°C
- Humidity (%): 33-50%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0600-1800 hours) in each 24-hour period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: methylcellulose

Details on oral exposure:

The test substance was formulated at a concentration of 20% w/v in 1% w/v aqueous methylcellulose and administered by oral gavage using a plastic syringe and catheter at a dose volume of 10 ml/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: soon after dosing, and at frequent intervals for the remainder of Day 1. On subsequent days :morning and afternoon
until day 15
- Frequency of weighing: day 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured in a group of 6 rats at a dose level of 2000 mg/kg of bw

Clinical signs:

other: No clinical signs were observed in any animals throughout the study

Gross pathology:

No abnormalities were revealed at the macroscopic examination at study termination on Day 15

Other findings:

No other findings

Any other information on results incl. tables

Table 7.2.1/2: Individual and group mean bodyweights (g) in treated animals during the observation period

Dose mg/kg	Animal n° and sex	Bodyweight (g) at
		Day 1 *	Day 8	A	Day 15	B
2000	3F	98	137	(39)	158	(21)
	4F	98	135	(37)	153	(18)
	5F	97	138	(41)	163	(25)
	Mean	98	137	(39)	158	(21)
	6M	107	147	(40)	198	(51)
	7M	105	151	(46)	197	(46)
	8M	106	168	(62)	214	(46)
	Mean	106	155	(49)	203	(48)

*: Prior to dosis

Bodyweight gain shown in parenthesis

A: Weight gain on Day 8 B: Weight gain on Day 15

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance was higher than 2000 mg/kg in rats.
Therefore, the substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.

Executive summary:

The substance was tested for acute oral toxicity according to OECD 423 guideline and in compliance with Good Laboratory Practices.

Groups of 3 rats/sex were administered by gavage a single dose of the test substance at 2000 mg/kg bw. Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period. No mortality and no clinical signs were observed throughout the study. body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.

The acute oral combined LD50 was found greater than 2000 mg/kg b.w.