Reaction mass of 1-(4-aminophenyl)-1,3,3-trimethylindan-5-amine and 3-(4-aminophenyl)-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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

Justification for type of information:

Testing was carried out prior to REACH, OECD guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Study was carried our prior to REACH guidelines and GLP

GLP compliance:

no

Remarks:

Study conducted prior to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Diamino Trimethylphenylindane

IUPAC Name:

Diamino Trimethylphenylindane

Test material form:

solid: particulate/powder

Details on test material:

Purity:
97.6% (49.9% 6-4’ isomer, 47.7 5-4’ isomer; per Protocol)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Young albino rabbits of the New Zealand strain were used in the evaluation
of the primary skin irritating properties of the test material. The test
procedure was modeled after that of Draize et al, *
Prior to the application of the test material, the hair was clipped from
the back and flanks of each rabbit. Two test sites located lateral to the midline
of the back approximately ten centimeters apart were selected. One of the
two sites was abraded by making four epidermal incisions, two perpendicular
to the other two, while the other test site remained intact.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Shaved and abraded

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Exactly 0.5 ml of undiluted test material (0.5 g of test material moistened
with a minimum amount of water in the case of solids) was applied to each of
the test sites on each rabbit.

Duration of treatment / exposure:

24 hours

Observation period:

Observations at 24 and 72 hours

Number of animals:

6

Details on study design:

Prior to the application of the test material, the hair was clipped from
the back and flanks of each rabbit. Two test sites located lateral to the midline
of the back approximately ten centimeters apart were selected. One of the
two sites was abraded by making four epidermal incisions, two perpendicular
to the other two, while the other test site remained intact.
Exactly 0.5 ml of undiluted test material (0.5 g of test material moistened
with a minimum amount of water in the case of solids) was applied to each of
the test sites on each rabbit. The test sites were immediately occluded with
two-inch square gauze patches. The patches were placed directly over the
test sites and secured with masking tape. The trunk of each animal was then
wrapped with impervious plastic sheeting. The wrap held the patches in position
and retarded evaporation of the test material during the 24-hour exposure
period.
At the end of 24 hours, the plastic wrappings, patches, and all residual
test material were removed. The intact and abraded test sites were
examined and scored separately for erythema and edema on a graded scale of
0 to 4. After 72 hours, the sites were again examined and scored.
In evaluating the average irritation present, the mean scores f ulerythema
and edema of the intact test sites after 24 and 72 hours were added.
Similarly, the mean scores for erythema and edema of the abraded test sites
after 24 and 72 hours were added. These two values were totaled and divided
by four to obtain the mean primary irritation score.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

not specified

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not reversible

Results 5

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 6

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 7

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not reversible

Results 8

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not reversible

Results 9

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not reversible

Results 10

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 11

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 12

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not reversible

Results 13

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not reversible

Results 14

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #4

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 15

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #4

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 16

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #4

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 17

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 18

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #5

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 19

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 20

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #5

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 21

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 22

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #6

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 23

Irritation parameter:

erythema score

Remarks:

Intact Skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 24

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #6

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 25

Irritation parameter:

edema score

Remarks:

Intact Skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Any other information on results incl. tables

Animal Number	Abraded 24 hours Erythema	Abraded 24 hours Edema	Abraded 72 hours Erythema	Abraded 72 hours Edema	Intact Skin 24 hours Erythema	Intact Skin 24 hours Edema	Intact Skin 72 hours Erythema	Intact Skin 72 hours Edema
1	2	0	2	0	2	0	2	0
2	2	0	2	0	2	0	2	0
3	2	0	2	0	2	0	2	0
4	2	0	2	0	2	0	2	0
5	2	0	0	0	2	0	0	0
6	2	0	0	0	2	0	0	0
Mean	2.0	0.0	1.3	0.0	2.0	0.0	1.3	0.0

Subtotals: 3.3

Primiary Irritation Score 1.6

Erythema scores at 24 and 72 hours are probably due to mechanical

irritation during the removal of the test material.

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Primiary Irritation Score 1.6 which is indicative of mild irritation.

Executive summary:

Young albino rabbits of the New Zealand strain were used in the evaluation

of the primary skin irritating properties of the test material. The test

procedure was modeled after that of Draize et al.

Prior to the application of the test material, the hair was clipped from

the back and flanks of each rabbit. Two test sites located lateral to the midline

of the back approximately ten centimeters apart were selected. One of the

two sites was abraded by making four epidermal incisions, two perpendicular

to the other two, while the other test site remained intact.

Exactly 0.5 ml of undiluted test material (0.5 g of test material moistened

with a minimum amount of water in the case of solids) was applied to each of

the test sites on each rabbit. The test sites were immediately occluded with

two-inch square gauze patches. The patches were placed directly over the

test sites and secured with masking tape. The trunk of each animal was then

wrapped with impervious plastic sheeting. The wrap held the patches in position

and retarded evaporation of the test material during the 24-hour exposure

period.

At the end of 24 hours, the plastic wrappings, patches, and all residual

test material were removed. The intact and abraded test sites were

examined and scored separately for erythema and edema on a graded scale of

0 to 4. After 72 hours, the sites were again examined and scored.

In evaluating the average irritation present, the mean scores f ulerythema

and edema of the intact test sites after 24 and 72 hours were added.

Similarly, the mean scores for erythema and edema of the abraded test sites

after 24 and 72 hours were added. These two values were totaled and divided

by four to obtain the mean primary irritation score.

Draize, John H., Woodard, Geoffrey, and Calvery, Herbert O., "Methods

for the Study of Irritation and Toxicity of Substances Applied Topically to

the Skin and Mucous Membranes," J. Pharm. & Exp. Ther. 82, 377 (1944).