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EC number: 268-452-3 | CAS number: 68092-28-4
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 September 2012 to 24 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tall oil, compd. with diethanolamine
- EC Number:
- 268-452-3
- EC Name:
- Tall oil, compd. with diethanolamine
- Cas Number:
- 68092-28-4
- Molecular formula:
- Example formula, based on oleic as the fatty acid: C18H35COOH.N(CH2CH2OH)2
- IUPAC Name:
- Tall oil, compd. with diethanolamine
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Hsdlf:NZW
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.25 or 2.95 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): Free access to mains drinking water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): At least 15 per hour.
- Photoperiod (hrs dark / hrs light): The lighting was controlled by a time switch to give twelve hours continuous light (0600 to 1800) and twelve hours darkness.
IN-LIFE DATES: From: 17 September 2012 To: 24 October 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize numerical evaluation.
Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects. Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period. Any clinical signs of toxicity, if present, were also recorded.
Draize Scale for Scoring Ocular Irritation
1. CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal............................................................................................................................................0
Vessels definitely injected above normal................................................................................................1
More diffuse, deeper crimson red, individual vessels not easily discernible....................................2
Diffuse beefy red.........................................................................................................................................3
Chemosis
No swelling..................................................................................................................................................0
Any swelling above normal (includes nictitating membrane).............................................................1
Obvious swelling with partial eversion of lids.......................................................................................2
Swelling with lids about half closed.........................................................................................................3
Swelling with lids half closed to completely closed...............................................................................4
Discharge
No discharge...............................................................................................................................................0
Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)......................................................................................................................1
Discharge with moistening of the lids and hairs just adjacent to lids...............................................2
Discharge with moistening of the lids and hairs a considerable area around the eye...................3
2. IRIS
Values
Normal.........................................................................................................................................................0
Folds above normal, congestion, swelling, circumcorneal injection (any or all
of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive).................................................................................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these)....................................2
3. CORNEA
Degree of Opacity (most dense area used)
No opacity...................................................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible......................................................................1
Easily discernible translucent areas, details of iris slightly obscured..............................................2
Opalescent areas, no details of iris visible, size of pupil barely discernible....................................3
Opaque, iris not discernible through the opacity................................................................................4
Area of Cornea Involved
One quarter (or less) but not zero..........................................................................................................1
Greater than one quarter but less than half...........................................................................................2
Greater than half but less than three quarters......................................................................................3
Greater than three quarters, up to whole area.......................................................................................4
TOOL USED TO ASSESS SCORE: Any additional ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- other: discharge score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Individual scores for ocular irritation are given in Table 1.
Scattered or diffuse corneal opacity was noted in both treated eyes one hour after treatment and at the 24, 48, 72 hour and 7 day observations.
Iridial inflammation was noted in all treated eyes one hour after treatment and at the 24 and 48 hour observations. Iridial inflammation was noted in one treated eye at the 72 hour observation and in both treated eyes at the 7 day observation.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment and at the 24, 48, 72 hour observations. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye at the 7 day observation. Minimal conjunctival irritation was noted in one treated eye at the 14 day observation.
One treated eye appeared normal at the 14 day observation and the other treated eye appeared normal at the 21 day observation. - Other effects:
- BODYWEIGHT
Both animals showed the expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1 Individual Scores for Ocular Irritation
Rabbit Number and Sex |
72425 Male |
72537 Male |
|||||||||||
IPR = 2 |
IPR = 2 |
||||||||||||
Time After Treatment |
1 hour |
24 hours |
48 hours |
72 hours |
7 days |
14 days |
1 hour |
24 hours |
48 hours |
72 hours |
7 days |
14 days |
21 days |
Cornea Degree Area |
1 1 |
1 1 |
1 2 |
1 2 |
1 1 |
0 0 |
1 2 |
1 2 |
1 2 |
1 2 |
1 2 |
0 0 |
0 0 |
Iris |
1 |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
Redness |
2 |
2 |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
Chemosis |
2 |
2 |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
2 |
2 |
1 |
0 |
Discharge |
2 |
2 |
1 |
1 |
0 |
0 |
3 |
3 |
2 |
1 |
1 |
0 |
0 |
IPR = Initial pain reaction; a score of 2 indicates slight initial pain. The rabbit blinks and tries to open the eye but reflex closes it.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritating to eyes) based on CLP criteria
- Conclusions:
- Eye irritant
- Executive summary:
The irritancy potential of the test material was assessed in vivo in accordance with the standardised guidelines OECD 405 and EU Method B.5 under GLP conditions.
A single application of the test material was sequentially administered to the right eye of two New Zealand White rabbits. The treated eyes were not irrigated; the left eye remained untreated and served as the control. The animals were observed for 21 days.
Administration of the test material produced scattered or diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 14 day observation; the other treated eye appeared normal at the 21 day observation.
Under the conditions of this study, the test material causes irritation to the eye and requires classification as Category 2 in accordance with EU criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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