Amines, N-C12–14 (even numbered)-alkyltrimethylenedi-, reaction products with chloroacetic acid and diethylenetriamine, N-C12–14 (even numbered)-alkyl derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 40 CFR, Subdivision F, par. 158.50 and 158.135; Section 81-5, pg. 55-59, Primary Dermal Irritation

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-{[3-(dodecylamino)propyl]amino}acetic acid; {2-[(2-aminoethyl)amino]ethyl}(dodecyl)amine

IUPAC Name:

2-{[3-(dodecylamino)propyl]amino}acetic acid; {2-[(2-aminoethyl)amino]ethyl}(dodecyl)amine

Test material form:

solid - liquid: aqueous solution

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: at least 2-3 kg
- Diet (e.g. ad libitum): rabbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 65-75°F
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped; intact + abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

6

Details on study design:

OBSERVATION TIME POINTS
1, 24, 48, and 72 hours after patch removal

SCORING SYSTEM:
Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal: 1-6

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal: 1, 3, 4, 5, 6

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

All animals displayed severe blistering and eschar formation.

Any other information on results incl. tables

Score at time point	Erythema, intact skin	Erythema, abraded skin	Edema, intact skin	Edema, abraded skin
	Max. score: 4	Max. score: 4	Max. score: 4	Max. score: 4
60 min	2/2/2/2/1/2	3/3/3/3/3/3	2/3/2/3/2/2	3/4/3/3/3/3
24 h	4/4/4/4/4/4	3/3/3/3/3/3	4/4/4/4/4/4	3/3/3/3/3/3
48 h	4/4/4/4/4/4	3/3/3/3/3/3	4/4/4/4/4/4	3/3/3/3/3/3
72 h	4/4/4/4/4/4	3/4/3/3/3/3	4/4/4/4/4/4	3/4/3/3/3/4
Average 24h, 48h, 72h	4/4/4/4/4/4	3/3.33/3/3/3/3	4/4/4/4/4/4	3/3.33/3/3/3/3.33

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

In this study, Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i.) was corrosive to rabbit skin.

Executive summary:

In a primary dermal irritation study according to 40 CFR, Subdivision F, par. 158.50 and 158.135; Section 81-5, 6 New Zealand White rabbits were dermally exposed to 0.5 mL of Reaction product of lauryl-PDA/lauryl-DETA with chloroacetic acid (22.5% a.i.) for 4 hours under semi-occlusive conditions.  Animals then were observed for 3 days.  Irritation was scored by the method of Draize.

Severe erythema (grade 4) and moderate to severe edema (grade 3-4) were observed after 24 h – 72 h. Reversibility cannot be fully judged as erythema scores of 4 and edema scores of 3 – 4 were still present at the end of the observation period of 3 days. As all animals displayed severe blistering and eschar formation, no full reversibility after 21 days is assumed. Thus, the substance is considered to be corrosive.