Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine

EC Number:

273-601-0

EC Name:

Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine

Cas Number:

68990-47-6

Molecular formula:

The substance is a UVCB substance. One of the most likely and the smallest molecule arising from the reaction process is assumed to be: C18H33O. C18H31O. 2C4H12N3 . C4H2O2

IUPAC Name:

Reaction product of 2,5-Furandione with reaction products of tall-oil fatty acids, diethylenetriamine, triethylenetetramine and tetraethylenepentamine

Details on test material:

Identification: Polyamide
CAS: No. 68990-47-6
Batch No.: CEM 2158/9
Characteristics: very viscous dark mass
Storage conditions: in a dark and cool place

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Conelli snc
- Age at study initiation: 2 - 3 months
- Weight at study initiation: 2 - 3 kg
- Housing: in the same room of the treatment
- Diet : ad libitum
- Water : from municipal water main

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ±2 °C
- Humidity (%): 55 ±10%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 h circadian cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 g/animal

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after the test article application. After the 24 hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution. Inspections for mortality and general clinical signs were made once a day.

Number of animals or in vitro replicates:

3 males

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 48

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

48 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24h

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

3

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

3

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24h

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

3

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24h

Results 11

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

4

Results 15

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Results 16

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Results 17

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

4

Results 18

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Results 19

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 20

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 21

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 22

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 23

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 24

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Other effects:

Neither mortality nor adverse general clinical modifications were observed during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article fatty acids, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine, administered to rabbits as a single ocular application, is to be considered non-irritant for the rabbit eye.

Executive summary:

In an OECD 405 eye damage/irritation study the test article fatty acids, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine, was administered as single application of 0.1 g to the right eye (the left eyes served as control) of three New Zealand White rabbits and reactions were scored 1, 24, 48 and 72 hours following removal of the substance. A further observation period was not required.

No general clinical signs were noted in any rabbit. Locally, at the application site, mild ocular changes, mainly consisting of conjunctival redness were noted up to 24 - 48 hours after treatment.

In conclusion, the test article fatty acids, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine, administered to rabbits as a single ocular application, is to be considered ”non-irritant” for the rabbit eye.