[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Remarks:

in vivo study was conducted prior to REACH implementation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-01-05 - 1995-01-16 (experimental phase)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

OECD-Guideline for Testing of Chemicals 405 "Acute Eye Irritation / Corrosion", adopted February 24, 1987.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate

Molecular formula:

C27H60NPS2O2 C28H62NPS2O2 C29H64NPS2O2 (main component)

IUPAC Name:

Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate

Test material form:

liquid

Details on test material:

Before Substance ID change known as CAS 71888-91-0 EC 276-159-7

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Zimmermann, Schweizer Hof, D-73453 Untergröningen/Aalen
- Housing: The rabbits housed individually in wire grating cages (area 2450 cm², height 42 cm) without bedding.
- Diet (e.g. ad libitum): Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P, Raiffeisen Kraftfutterwerk Kehl, ad libitum.
- Water (e.g. ad libitum): Community tap water from Karlsruhe; free access for the animals by daily changing of the watering-bottles.
- Acclimation period: The animals were acclimated to the test conditions for 5 days prior to the administration.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 ° C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES:
Acclimatization: January 05, 1995 - January 09, 1995
Administration: January 10, 1995
Observation: January 10, 1995 - January 16, 1995

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1 week

Number of animals or in vitro replicates:

3 animals, Identification numbers: female: 002, male: 007 and 008

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 h after administration the eye was carefully rinsed with NaCl 0.9 % in order to remove the residual test substance.

SCORING SYSTEM: according to table 1 of OECD-Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

identical in all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: n/a

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

identical in all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: n/a

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

No. 002, female

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: day 3

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

No. 007, male

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: day 2

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

No. 008, male

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: day 2

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

No. 002, female

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: day 2

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

No. 007, male

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: day 2

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

No. 008, male

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: day 2

Irritant / corrosive response data:

EYE REACTION
The test substance was applied undiluted in a dose of 0.1 ml into the right eye to each of 3 albino rabbits.
After evaluation of the eye reaction according to table 1 of the OECD-Guideline 405, all three rabbits developed the diffuse, crimson colour of the conjunctivae. Individual vessels were not easily discernible. These effects were estimated at grade 2 (maximum possible 3). Hyperemic blood vessels were not observed any more on day 2 (rabbit No. 007 and 008) or on day 3 (rabbit No. 002).
Furthermore, all three animals showed swelling of lids. This effect was estimated at grade 3 (rabbit No. 002) or at grade 2 (rabbit No. 007 and 008) (maximum possible 4). Swelling of lids was not observed any more on the 48th hour.
No rabbit showed any exsudation after administration and during the observation period.
Irritations and lesions of cornea or iris could not be observed.
The effects on conjunctivae attributed to the test item are reversible which was revealed by the last four days of the observation period.
In the untreated left eye which was used as control pathological symptoms could not be noted.

Other effects:

- Other observations:

MORTALITY/TOXICOLOGICAL SYMPTOMS
After the administration of 0.1 ml test substance into the right eye none of the treated rabbits died during the experiment and observation period. Toxicological symptoms could not be observed.

BEHAVIOUR
The general behaviour of the rabbits treated was quiet and watchful. The behaviour pattern was not different to that of other rabbits which were not in the test.

BODY WEIGHT
During the experiment the body weight of all three rabbits increased.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

This study was performed in compliance with OECD-Guideline 405 under GLP, is well-documented and with sufficient information for classification, the results can hence be considered as reliable.
After evaluation of the eye reaction according to table 1 of the OECD-Guideline 405, all three rabbits developed the diffuse, crimson colour of the conjunctivae. Individual vessels were not easily discernible. These effects were estimated at grade 2 (maximum possible 3). Hyperaemic blood vessels were not observed any more on day 2 (rabbit No. 007 and 008) or on day 3 (rabbit No. 002).
Furthermore, all three animals showed swelling of lids. This effect was estimated at grade 3 (rabbit No. 002) or at grade 2 (rabbit No. 007 and 008) (maximum possible 4). Swelling of lids was not observed anymore on the 48th hour.
Irritations and lesions of cornea or iris could not be observed.
According to Regulation 1272/2008, a substance must be classified as eye irritant Cat. 2, if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
Those gradings were not observed in the test. Cornea opacity score and Iris score were zero in all animals and all observation time points. Conjunctivae redness scores, mean over 24, 48, and 72h, were 1.0, 0.33, and 0.33 in the individual animals, and chemosis scores were each 0.33.
So, the criteria set out in Regulation 1272/2008 are not met here, and the substance does not need to be classified as irritating to the eyes.

Executive summary:

This experiment was performed as an "Acute Eye Irritation/Corrosion"-study in compliance with the OECD-Guideline for Testing of Chemicals 405 under GLP. The test substance was applied undiluted in a single dose of 0.1 ml into the right eye to each of 3 albino rabbits.

After evaluation of the eye reaction according to table 1 of the OECD-Guideline 405, all three rabbits developed the diffuse, crimson colour of the conjunctivae. Individual vessels were not easily discernible. These effects were estimated at grade 2 (maximum possible 3). Hyperaemic blood vessels were not observed any more on day 2 (rabbit No. 007 and 008) or on day 3 (rabbit No. 002)

Furthermore, all three animals showed swelling of lids. This effect was estimated at grade 3 (rabbit No. 002) or at grade 2 (rabbit No. 007 and 008) (maximum possible 4). Swelling of lids was not observed any more on the 48th hour.

Irritations and lesions of cornea or iris could not be observed.

Cornea opacity score and Iris score were zero in all animals and all observation time points. Conjunctivae redness scores, mean over 24, 48, and 72h, were 1.0, 0.33, and 0.33 in the individual animals, and chemosis scores were each 0.33.

Under the conditions of this experiment the test substance did not cause mortality. Toxicological symptoms could not be noted.

All symptoms observed turned out to be reversible.

The left eye was not treated and was used for control. Symptoms of eye irritation did not occur on this eye.

During the experiment all three animals had a weight gain.

GHS criteria are not met, the substance does not need to be classified as irritating to the eyes.