Amines, C16-18-alkyl

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1 March 1995 to 20 July 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, hydrogenated tallow alkyl

EC Number:

262-976-6

EC Name:

Amines, hydrogenated tallow alkyl

Cas Number:

61788-45-2

IUPAC Name:

61788-45-2

Constituent 2

Reference substance name:

Hydrogenated Tallow Alkylamines

IUPAC Name:

Hydrogenated Tallow Alkylamines

Details on test material:

- Name of test material (as cited in study report): Farmin TH

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: B&K UNIVERSAL G.J., S.L
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 2.3-2.5
- Housing: were individually in stainless steel cages with a grille floor
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 45-66
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated left eye was used as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg/animal

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours as well as 7, 14 and 21 days post exposure

Number of animals or in vitro replicates:

3

Details on study design:

The observation of the cornea was completed with the installation of an aqueous solution of 2% sodium fluorescein. This procedure involved the installation of the aqueous solution of fluorescein in the test area, followed by washing the area with a 0.9% physiological saline solution.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

3.33

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: exposure 24 hours

Results 2

Irritation parameter:

iris score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: exposure 24 hours

Results 3

Irritation parameter:

conjunctivae score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: exposure 24 hours

Results 4

Irritation parameter:

chemosis score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48 and 72 hours

Score:

3.11

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: exposure 24 hours

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the findings of this study, the test material Farmin TH is considered to be severely irritating to eyes.

Executive summary:

In an GLP compliant OECD TG 405 study, 100 mg the test substance Farmin TH (hydrogenated tallow alkyl amine), a white solid (pH = 9.93, purity 95%), was applied to the eyes of three New Zealand White rabbits. Pronounced conjunctiva redness and chemosis was observed throughout the entire observation period. Additionally, severe cornea opacity and moderate iris lesions was noted. Mean Draize scores for conjunctiva redness at 24, 48 and 72 hours were 3.0, 3.0 and 3.0. Mean scores for conjunctiva chemosis were 3.0, 3.0 and 3.3 for the same time points. These effects were not reversible within the observation period of 21 days. Related scores for iris were 1.0, 1.0 and 1.0, reversible between 14 and 21 days. Scores for cornea density were 3.0, 3.3 and 3.7, respectively and showed a value of 2.0 at the end of the observation period. Based on the findings of this study, the test material Farmin TH is considered to be severely irritating to eyes.