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EC number: 412-780-3 | CAS number: 1380226-46-9 ADDITIV 104
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 June 1993 to 30 June 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)
- EC Number:
- 412-780-3
- EC Name:
- Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)
- Cas Number:
- 1380226-46-9
- Molecular formula:
- A complex mixture of species so no unique molecular formula can be given
- IUPAC Name:
- dimolybdenum(6+) diammonium 2-{2-[(octadec-9-en-1-yl)amino]ethoxy}ethan-1-ol heptaoxidandiide
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material: Additiv 104-Konzentrat
- Description: Dark red liquid
- Purity: Product by process; treated as 100% pure
- Lot/batch No.: OS 147
- Expiration date of the lot/batch: March 9, 1994
- Storage condition of test material: room temperature in the dark
- Stability under storage conditions and up to 60 degrees C: stable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2208 - 2468 grams
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): relative humidity of 55%
- Air changes (per hr): Air-conditioned with 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
-amount applied: 0.1 ml - Duration of treatment / exposure:
- Prior to test substance administration, the animals were physically examined and the eyes were found to be normal.
On test day 1, the test substance (0.1 ml) was instilled in the conjunctival sac of an eye of one animal after gently pulling the lower lid away from the
eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. - Observation period (in vivo):
- - Eye reactions: assessed at approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance.
- Viability/mortality/toxicity- assessed twice daily throughout duration of study.
- Bodyweight was recorded on day of treatment (prior to instillation) - Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- SCORING SYSTEM:
The following numerical scoring system was used to score the eye lesions:
CORNEA
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity - 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible - 1
Easily discernible translucent area, details of iris slightly obscured - 2
Nacreous areas, no details of iris visible, size of pupil barely discernible - 3
Opaque cornea, iris not discernible through the opacity - 4
Area of cornea affected
No ulceration or opacity - 0
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
IRIS
Normal - 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or any combination thereof, iris still reacting to light (sluggish reaction is positive) - 1
No reaction to light, haemorrhage, gross destruction (any or all of these) - 2
CONJUNCTIVAE
Redness (refers to palpebrae and sciera, excluding cornea and iris):
Blood vessels normal - 0
Some blood vessels definitely hyperaemic (injected) - 1
Diffuse, crimson colour, individual vessels not easily discernible - 2
Diffuse beefy red - 3
Chemosis: lids and/or nictitating membrane
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 more than half 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, in a considerable area around the eye - 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 3
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.3
- Irritation parameter:
- chemosis score
- Max. score:
- 3
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- IRRITATION:
Instillation of the test substance into one eye of each of the three male albino rabbits affected the iris in one animal and conjunctivae in all three
animals. The iridic irritation had resolved within 24 hours after instillation in one animal. The irritation of the conjunctivae had resolved within 14 days
in all animals, although lacrimation was still observed in one animal at the final observation.
Treatment of the eyes with 2% fluorescein, 24 and/or 72 hours after test substance instillation revealed no corneal epithelial damage in any of the
animals.
CORROSION:
There was no evidence of ocular corrosion.
REVERSIBILITY OF ANY OBSERVED EFFECTS:
Changes fully reversible within 7 days - Other effects:
- No toxic symptoms were observed in the animals during the test period and no mortality occurred.
Brown staining of the outside of the eyelids and the fur on the head and paws of the animals, caused by the test substance, was observed during the study
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- At the time of testing the test substance was considered mildly irritating to the rabbit eye (Kay and Calandra interpretation of the calculated maximum Draize score: 11). However according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures the test substance is classifed as an eye irritant (Category 2) as a positive response was noted in 2 of the 3 tested animals (conjunctival redness ≥2).
- Executive summary:
In a GLP compliant, guideline 'Acute Toxicity: Eye Irritation/Corrosion' test a positive response was noted in 2 of the 3 tested animals (conjunctival redness ≥2). Therefore the test substance is classified as an eye irritant (Category 2) according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. It is reasonable to assume that the Signal Word “Warning” and the Hazard Statement “H319: Causes serious eye irritation” are therefore required
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