tert-butyl bromoacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June from 02nd to 11th, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted on 24th,02,1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl bromoacetate

EC Number:

226-133-6

EC Name:

tert-butyl bromoacetate

Cas Number:

5292-43-3

Molecular formula:

C6H11BrO2

IUPAC Name:

tert-butyl bromoacetate

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
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: ca. 8 weeks.
- Weight at study initiation: at least 200 g.
- Fasting period before study: overnight before dosing.
- Housing: polypropylene cages.
- Diet: Rat and Mouse Expended Diet no. 1.
- Water: free access to tapwater.
- Acclimation period: at least 5 days.
- Identification: ink-marking on the tail.

ENVIRONMENTAL CONDITIONS
- Temperature:19 - 25 °C
- Humidity: 30 - 70 %
- Air changes: at least 15 ACH
- Photoperiod: 12 hours dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Coverage: 10 % of the total body surface area.

REMOVAL OF TEST SUBSTANCE
- Modality: treated skin wiped with cotton wool moistoned with distilled water.
- Time after start of exposure: after 24 hours the bandage was removed.

TEST MATERIAL
- Amount applied: 1.54 ml/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males per 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- Body weights
- Necropsy of survivors performed: yes

EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema...................................................0
Very slight erythema (barely perceptible)......1
Well-defined erythema....................................2
Moderate to severe erythema.........................3
Severe erythema to slight eschar formation...4

Oedema formation
No oedema..............................................................................................................0
Very slight oedema (barely perceptible).................................................................1
Slight oedema (edges well-defined)........................................................................2
Moderate oedema (raised ca. 1 mm).......................................................................3
Severe oedema (raised more than 1 mm; extending beyond area of exposure)....4

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: No signs of systemic toxicity.

Gross pathology:

No abnormalities noted.

Other findings:

No signs of dermal irritation in male animals.
Female animals showed light brown discoloration of the epidermis, small superficial scattered scabs and glossy skin.

Any other information on results incl. tables

Females individual dermal reactions

Dose level mg/kg b.w.	Animal no. and sex	Observation	Effects noted after initiation of exposure (days)
			1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1F	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Other	-	Br	Br	Br	Br	Br	Br	BrSs	BrSs	SSG	SSG	SSG	G	G
	2F	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Other	-	Br	Br	Br	Br	Br	Br	BrSs	BrSs	SSG	SSG	SSG	G	G
	3F	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Other	-	Br	Br	Br	Br	Br	Br	BrSs	BrSs	SSG	SSG	SSG	G	G
	4F	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Other	-	Br	Br	Br	Br	Br	Br	BrSs	BrSs	SSG	SSG	SSG	G	G
	5F	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
		Other	-	Br	Br	Br	Br	Br	Br	BrSs	BrSs	SSG	SSG	SSG	G	G

Br = light brown discoloration of the epidermis; G = glossy skin; Ss = small superficial scattered scabs

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

The test was performed according to OECD 402 (1987).

A group of ten animals (5 males and 5 females) was given a single 24 -hour semi-occluded dermal application of undiluted test material at dose level of 2000 mg/kg b.w.

No deaths occurred. No signs of systemic toxicity and abnormalities at necropsy were noted.

Skin of male animals was not affected by the test material; light brown discoloration of the epidermis, small superficial scattered scabs and glossy skin were noted in females.

Conclusion

The acute dermal LD50 is higher than 2000 mg/kg bw