Reaction products of amines, dicoco alkyl and glycollic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 November 2005 - 29 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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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:

male/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: at least 200 g
- Fasting period before study: none
- Housing: animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK was provided ad libitum
- Water: 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: To: 15/11/2005 - 29/11/2005

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10 % of total body surface area
- Type of wrap if used: surgical gauze covered with self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.27 mL/kg bw
- Concentration (if solution): the test material was used undiluted as supplied
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): Not apllicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The 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 application of the test material on Day 0 and on Days 7 and 14.
- 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:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: Number of animals: 5; Number of deaths: 0
Female: Number of animals: 5; Number of deaths: 0

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

- Other observations: Individual dermal reactions are given in Table 2 below. Very slight erythema was noted at all treatment sites one and two days after dosing. Crust formation was noted at the treatment sites of three males and three females three to five days after treatment. Treatment sites appeared normal three or six days after treatment.

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 male	299	348	399	49	51
	1-1 male	299	344	386	45	42
	1-2 male	297	346	383	49	37
	1-3 male	296	323	354	27	31
	1-4 male	300	346	383	46	37
	2-0 female	222	236	240	14	4
	2-1 female	232	240	249	8	9
	2-2 female	242	257	271	15	14
	2-3 female	242	245	266	3	21
	2-4 female	207	213	222	6	9

Table 2: Individual dermal reactions

Dose level (mg/kg)	Animal No. & sex	Observation	Effects noted after initiation of exposure (Days)
			1	2	3	4	5	6-14
2000	1-0 male	Erythema Oedema Other	1 0 0	1 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	1-1 male	Erythema Oedema Other	1 0 0	1 0 0	0 0 Cf	0 0 Cf	0 0 Cf	0 0 0
	1-2 male	Erythema Oedema Other	1 0 0	1 0 0	0 0 Cf	0 0 Cf	0 0 Cf	0 0 0
	1-3 male	Erythema Oedema Other	1 0 0	1 0 0	0 0 Cf	0 0 Cf	0 0 Cf	0 0 0
	1-4 male	Erythema Oedema Other	1 0 0	1 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	2-0 female	Erythema Oedema Other	1 0 0	1 0 0	0 0 Cf	0 0 Cf	0 0 Cf	0 0 0
	2-1 female	Erythema Oedema Other	1 0 0	1 0 0	0 0 Cf	0 0 Cf	0 0 Cf	0 0 0
	2-2 female	Erythema Oedema Other	1 0 0	1 0 0	0 0 Cf	0 0 Cf	0 0 Cf	0 0 0
	2-3 female	Erythema Oedema Other	1 0 0	1 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	2-4 female	Erythema Oedema Other	1 0 0	1 0 0	0 0 0	0 0 0	0 0 0	0 0 0

0 = no reactions; Cf = crust formation

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 male and female Sprague-Dawley rats, had an acute dermal LD50 of greater than 2000 mg/kg bodyweight

Executive summary:

Test Guidance

OECD Guideline 402 (Acute Dermal Toxicity)

Method and materials

In an acute dermal toxicity study, undiluted test material was applied to the shaved back and flanks of ten rats (5 males and 5 females) at a dose level of 2000 mg/kg bw. The test material was covered with a semi-occlusive dressing for a period of 24 hours. At the end of the exposure period any residual test material was removed and the animals were observed for 14 days.

Results

There were no deaths or clinical signs of toxicity during the study. Animals showed expected gains in bodyweight. Very slight erythema was noted at all treatment sites one and two days after dosing. Crust formation was noted at the treatment sites of three males and three females three to five days after treatment. Treatment sites appeared normal three or six days after treatment. Gross pathologic examination revealed nothing remarkable. The dermal LD50 of the test material in male and female rats has been determined to be greater than 2000 mg/kg bw.

Conclusion

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