Reaction products of amines, dicoco alkyl and glycollic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 November 2005 - 28 November 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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 (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: dark amber slightly viscous liquid
- Analytical purity: No data
- Stability under test conditions: undetermined
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 189-218 g
- Fasting period before study: Feed (not water) was withheld overnight prior to dosing.
- Housing: The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK was provided ad libitum
- Water (e.g. ad libitum): tap water was available ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle.

IN-LIFE DATES: From: 07/11/2005 To: 28/11/2005.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Not applicable.
- Amount of vehicle (if gavage): Not applicable.
- Justification for choice of vehicle: Not applicable.
- Lot/batch no. (if required): Not applicable.
- Purity: Not applicable.

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual): Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on consideration of all available information on the toxicity of the test material

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 groups of 3 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: gross necropsies were performed on all animals after sacrifice at the conclusion of the 14 day observation period.

Statistics:

No data available

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

Number of animals: 6; Number of deaths: 0

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No gross abnormalities were noted in all animals

Any other information on results incl. tables

Table 1: Individual bodyweights and weekly bodyweight changes

Dose level (mg/kg)	Animal No. & sex	Bodyweight (g) at Day			Bodyweight gain (g) during Week
		0	7	14	1	2
2000	1-0 female	218	246	277	28	31
	1-1 female	200	232	264	32	32
	1-2 female	217	259	280	42	21
	2-0 female	189	223	236	34	13
	2-1 female	209	249	262	40	13
	2-2 female	213	254	264	41	10

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article, when administered as received to female Sprague-Dawley rats, had an acute oral LD50 of greater than 2500 mg/kg bodyweight

Executive summary:

Test Guidance

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

Method and material

In an acute oral toxicity study, two groups of fasted Sprague-Dawley rats (three females/group) were given a single oral dose by gavage of undiluted test material at a dose level of 2000 mg/kg bw and observed for 14 days.

Results

There were no deaths or clinical signs of toxicity during the study. Animals showed expected gains in bodyweight. Gross pathologic examination revealed nothing remarkable. The oral LD50 of the test material in female rats has been determined to be greater than 2500 mg/kg bw.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute oral toxicity