4,4',4''-triaminotrityl alcohol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment report.

Data source

Reference

Reference Type:

secondary source

Title:

Acute Toxicity, Skin and Eye Irritancy and Skin Sensitization Potential of Ancamine D.

Author:

NTRL (National Technical Reports Library)

Year:

1986

Bibliographic source:

NTRL REPORT; OTS0511923; 15/10/1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The primary skin irritation study of 4,4'-Methylenedianiline (CAS No: 101-77-9) was conducted on New Zealand White rabbits according to Draize under occlusive condition.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-methylenedianiline

EC Number:

202-974-4

EC Name:

4,4'-methylenedianiline

Cas Number:

101-77-9

Molecular formula:

C13H14N2

IUPAC Name:

4, 4’- diaminodiphenylmethane

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report):4,4'-Methylenedianiline
- Molecular formula :C13H14N2
- Molecular weight :198.268 g/mol
- Substance type:Organic
- Physical state:Solid
-Smiles: c1(Cc2ccc(N)cc2)ccc(N)cc1
-InChI: 1S/C13H14N2/c14-12-5-1-10(2-6-12)9-11-3-7-13(15)8-4-11/h1-8H,9,14-15H2

Specific details on test material used for the study:

- Name of test material (as cited in study report):4,4'-Methylenedianiline
- Molecular formula :C13H14N2
- Molecular weight :198.268 g/mol
- Substance type:Organic
- Physical state:Solid
-Smiles: c1(Cc2ccc(N)cc2)ccc(N)cc1
-InChI: 1S/C13H14N2/c14-12-5-1-10(2-6-12)9-11-3-7-13(15)8-4-11/h1-8H,9,14-15H2

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ranch Rabbits Crawley, Suasex

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

Amount :500mg
concentration applied :100%

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

8 (4/sex)

Details on study design:

TEST SITE
- Area of exposure: shoulders and the hindquarters
- Type of wrap if used: occlusive polyethylene which was secured in position by mean of an elastic adhesive bandage (3" Poroplast).

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 hours
SCORING SYSTEM: Draize method.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

In one rabbit, the abraded patch had a 'bruised' appearance, this was thought to be due to damage of the dermis during abrasion.

Any other information on results incl. tables

TABLE:1.ERYTHEMA AND OEDEMA SCORING SYSTEM
ERYTHEMA	OEDEMA
No erythema                                                               =0	No oedema                                                                 =0
Pale pink                                                                      =1	Soft skin                                                                       =1
Redness                                                                      =2	Oedema                                                                       =2
Severe redness                                                           =3	More definite oedema                                              =3
Beet redeness                                                            =4	Severe oedema                                                          =4

TABLE:2.Primary irritation scores
Animal No.	Sex	Response	24 hours		48 hours		72 hours		7 days
			Ab	N-AB	Ab	N-AB	Ab	N-AB	Ab	N-AB
51	Male	Erythema	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0
52	Male	Erythema	0-1	0-1	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0
53	Male	Erythema	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0
54	Male	Erythema	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0
55	Female	Erythema	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0
56	Female	Erythema	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0
57	Female	Erythema	2-3*	0	2	0	1	0	0	0
		Oedema	0	0	0	0	0	0	0	0
58	Female	Erythema	0	0	0	0	0	0	0	0
		Oedema	0	0	0	0	0	0	0	0
Reading: 0=no erythema to 4= beet redness;  Reading :0=no oedema to 4=severe oedema             comments: Abrasions deeper than stratum corneum Note: Ab= Abraded patch ; N-Ab= Not abraded patch

Applicant's summary and conclusion

Interpretation of results:

other: Not Irritating

Conclusions:

The test chemical 4,4'-Methylenedianiline (CAS No: 101-77-9) was considered to be not irritating to the New Zealand White rabbits’ skin.

Executive summary:

The primary skin irritation study of 4,4'-Methylenedianiline (CAS No: 101-77-9) was conducted on eight (4/sex)New Zealand White rabbits according to Draize method to determine its skin irritation efficacy.

 

The 500mg of undiluted chemical was applied to the intact and abraded skin of shornshoulders and the hindquartersof each rabbit under occlusive condition for 24 hours. A 2 x 2 cm area of the shorn skin was abraded using a fine hypodermic needle. Injuries were deep enough to disturb the stratum corneum but not sufficiently deep to cause bleeding. The patches were covered by an occlusivepolyethylene which was secured in position by mean of an elastic adhesive bandage (3" Poroplast).

 

Reactions were assessed visually for the degree of erythema and oedema upto 7 days. In one rabbit, the abraded patch had a bruised appearance. This was thought to be due to damage of the dermis during abrasion.

 

Since none of the rabbit showed erythema or edema, the chemical 4,4'-Methylenedianiline (CAS No: 101-77-9) was considered to be not irritating to the New Zealand White rabbits’ skin.