tert-butylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1962

Report date:

1962

Materials and methods

Principles of method if other than guideline:

BASF Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butylamine

EC Number:

200-888-1

EC Name:

tert-butylamine

Cas Number:

75-64-9

Molecular formula:

C4H11N

IUPAC Name:

2-methylpropan-2-amine

Details on test material:

- Name of test material (as cited in study report): tert-butylamine
- no further data

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.28 and2.25 kg
- Housing: individual
- Diet ad libitum
- Water ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: concurrent phys. saline

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

not applicable, test substance remained in the eye and was not washed out

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none


SCORING SYSTEM: The original scoring system was converted into Draize scores

Results and discussion

In vivo

Results

Irritation parameter:

other:

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

> 4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: severe eye damage, endpoints erythrema and chemosis therefore not scored

Any other information on results incl. tables

Readings	Animal	Cornea		Iris	Conjunctiva			Additional findings
		op	ar		red	ch	di
10 min	1	-	-	-	-	-	-	chemical burns of eye ball, nictitating membrane and conjunctiva
	2	-	-	-	-	-	-	chemical burns of eye ball, nictitating membrane and conjunctiva
1 h	1	-	-	-	-	-	-	chemical burns of conjunctiva (brown-colored appearance), milky opacity
	2	-	-	-	-	-	-	chemical burns of conjunctiva (brown-colored appearance), milky opacity
24 h	1							chemical burns of eye ball, nictitating membrane and conjunctiva
	2	-	-	-	-	-	-	chemical burns of eye ball, nictitating membrane and conjunctiva
48 h	1	-	-	-	-	-	-	chemical burns of eye ball, nictitating membrane and conjunctiva, ulceration, chemosis of the surrounding tissue
	2	-	-	-	-	-	-	chemical burns of eye ball, nictitating membrane and conjunctiva, ulceration
72 h	1	-	-	-	-	-	-	chemical burns of eye ball, nictitating membrane and conjunctiva, ulceration, chemosis of the surrounding tissue
	2	-	-	-	-	-	-	chemical burns of eye ball, nictitating membrane and conjunctiva, ulceration
7 d	1	-	-	-	-	-	-	necrosis on eyelids, blepharophimosis, chemosis not assessable; eyes clotted with pus
	2	-	-	-	-	-	-	necrosis and swelling of eyelids, pus secretion, corneal lesions with loss of lens

- endpoint not scored because of severe damage of the eye