Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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

Applicant's summary and conclusion