Reaction mass of pentadecylamine and tridecylamine and 2-Methyldodecylamine and 2-Methyltetradecylamine

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:

other: Study based on national and scientific standards, basic data given, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

other: Summary report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

according to standard procedure, grading of effects based on the numerical scoring systems after Draize 1959

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C12-18-alkyl

EC Number:

268-953-7

EC Name:

Amines, C12-18-alkyl

Cas Number:

68155-27-1

Molecular formula:

mixture of C13 [C13H29N] and C15 [C15H33N]-branched and linear amines

IUPAC Name:

Amines, C12-18-alkyl

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Synprolam 35 (trade name)
- Substance type: organic
- Physical state: liquid, clear
- Melting point: 12.5 °C
- Boiling point: 263 °C
- Density: 0.806 g/mL (20 °C)
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data in the Report
data adopted from the precursor aldehyde mixture (SYNPRAL 135):
- n-tridecylamine 33 % (m/m)
- isotridecylamine 33 % (m/m)
- n-pentyldecylamine 14 % (m/m)
- isopentylamine 14 % (m/m)
- other components 6 % (m/m)

[Reference: ICI 1975/1976: Synthetic fatty amines - Synpral 135 (Synprolaldehyde; C13/C15 alkyl aldehyde). MSDS]

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Huntingdon
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

not rinsed

Observation period (in vivo):

2 days

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: numerical scale according to Draize, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Appendix 2, 1959.
The results were interpreted using a modification of the method recommended by Kay and Calandra, Journal of the Society of Cosmetic Chemists, 13 (6), 281-9, Appendix 3, 1962.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal: 1, 2, 3

Time point:

other: day 1 and 2

Score:

110

Max. score:

110

Reversibility:

not reversible

Remarks on result:

other: not quantitively evaluable / descriptive rating: very to extremely severe irritant

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 11

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 12

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Results 13

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Due to the severity of the reactions the animals were all sacrificed on day 2.

Irritant / corrosive response data:

Corneal damage in all animals, severe conjunctival swelling extending beyond the limits of the orbit, resulting in total eye closure.
No assessment of the degree of inflammation reaction possible.
All three animals had to be killed on day 2 for humane reasons.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

On instillation of the test item the animals showed moderate initial pain.
Corneal damage was produced in all three animal but assesment of the degree and extent was precluded by the severe conjuctival swelling. Considerable swelling of the conjuctivae extending well beyond the limits of the orbit resulting in complete closure of the eye was observed in all three rabbits. It was impossible to asses the degree of inflammation.
Due to the severity of the reactions the animals were all sacrificed on day 2.

Executive summary:

In an in vivo eye irritation study three albino rabbits of the New Zealand White strain were treated with 1 drop (0.1 mL) of the test substance per one eye.

The test item caused moderate to severe initial pain (3 -4 on a 5 point scale according to Kay and Calandra, 1962) which was followed by extremely severe irritation which was impossible to score. No readings could be taken if the iris and cornea due to swelling accomapnied by a great amount of discharge. Histopathological examination of sections of the eye 2 days after the installation showed the material to cause severe conjunctivitis, diffuse necrosis and inflammation of the anterior chamber.