Ammonium chloride

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test substance is applied to the conjunctival sac of one eye in 2 animals. The substance was tested as powder. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium chloride

EC Number:

235-186-4

EC Name:

Ammonium chloride

Cas Number:

12125-02-9

Molecular formula:

ClH4N

IUPAC Name:

ammonium chloride

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.69 and 2.82 kg

ENVIRONMENTAL CONDITIONS: not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye treated with talcum

Amount / concentration applied:

Amount applied: 50 mg

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Initially, a BASF scoring system was used to score eye changes. These values were adapted to OECD Draize scores (see below).

TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of both animals

Time point:

other: 24 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24 and 72 hours

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

of both animals

Time point:

other: 24 and 72 hours

Score:

0.167

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 and 72 hours

Score:

2.5

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Bleeding seen after 72 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 and 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of both animals

Time point:

other: 24 and 72 hours

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 and 72 hours

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of both animals

Time point:

other: 24 and 72 hours

Score:

1.25

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Slight erythema and chemosis was seen in the control eyes 1 hour and 24 hours after instillation of amorphous talcum. The effects were no longer present by the 72 hour observation time point (table 3).

Any other information on results incl. tables

Table 2: OECD Draize scores after treatment of the rabbit eye with Ammonium Chloride

Time	opacity	iritis	erythema	chemosis	Comments
1 h	2/2	0/0	2/1	2/2
24 h	2/2	0/0	3/2	1/2
48 h	-/-	-/-	-/-	-/-
72 h	2/2	0/1	2/2	1/1	bleeding in animal 1
8 d	0/0	0/0	0/0	0/0

"-": data missing.

 

Table 3: OECD Draize scores after treatment of the rabbit eye with amorphous Talcum (Control eye)

Time	opacity	iritis	erythema	chemosis	Comments
1 h	0/0	0/0	2/1	1/0	Residue in both animals
24 h	0/0	0/0	2/2	0/0
48 h	-/-	-/-	-/-	-/-
72 h	0/0	0/0	0/0	0/0
8 d	0/0	0/0	0/0	0/0

"-": data missing.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria