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EC number: 915-586-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5-28-1993 to 5-31-1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: EPA/OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol
- EC Number:
- 915-586-1
- Molecular formula:
- Variable; substance is a UVCB.
- IUPAC Name:
- Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol
- Test material form:
- other: Semi-solid
- Details on test material:
- The test material was a red colored semi-solid, identified as Automate Yellow 8 Petroleum. The test material was administered undiluted. Records of the test article stability, purity, source and other data required by Federal Regulations will be maintained by the Sponsor.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One group of six male New Zealand White rabbits were used for this study. The rabbits were obtained from Oak Hill, Holland, Michigan, and weighed between 2.24 and 2.85 kg. at study initiation.
The rabbits were identified by ear tags and were individually housed in stainless steel cages in a temperature, humidity, and light controlled room. The animals were maintained according to the recommendations contained in DHHS Publication No. 86-23 (NIH): Revised 1985, "Guide for the Care and Use of Laboratory Animals." They were conditioned for 5 days prior to study initiation. Purina Rabbit Chow (ca. 350 gm) was placed in the feeders each morning during the study. Tap water from an automatic watering system was provided ad libitum from arrival until termination. Six animals were selected randomly from the acclimated colony and assigned to the test group.
Justification for Selection of Test System: The New Zealand Albino rabbit has been used extensively for eye irritation evaluations.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye served as the untreated control for each rabbit.
- Amount / concentration applied:
- 0.1 g of undiluted test material.
- Duration of treatment / exposure:
- Single exposure.
- Observation period (in vivo):
- The treated eyes were examined and scored at 1, 24, 48 and 72 hours after treatment. A solution of 2% sodium fluorescein and ultraviolet light were employed to reveal possible corneal injury. Scoring was performed in accordance with the Draize Scale For Scoring Ocular Lesions (Table 1).
- Number of animals or in vitro replicates:
- 6 animals.
- Details on study design:
- The test material (0.1 g) was flattened into a small wafer and was instilled into the conjunctival sac of the right eye of each rabbit, and the eyelids were held together for one second.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0.28
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
Any other information on results incl. tables
Table 2: INDIVIDUAL AND GROUP MEAN BODY WEIGHTS
Animal # |
Initial Weight (kg) |
Final Weight (kg) |
432 |
2.62 |
2.58 |
438 |
2.68 |
2.73 |
442 |
2.24 |
2.32 |
446 |
2.53 |
2.59 |
447 |
2.47 |
2.47 |
451 |
2.85 |
2.79 |
Mean |
2.57 |
2.58 |
+SD |
0.21 |
0.17 |
Table 3: INDIVIDUAL EYE IRRITATION SCORES
Animal # 432 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
1 |
1 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
0 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
2 |
2 |
0 |
0 |
Animal # 438 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
1 |
1 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
1 |
1 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
4 |
4 |
0 |
0 |
Animal # 442 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
1 |
1 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
1 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
4 |
2 |
0 |
0 |
Animal # 446 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
0 |
0 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
0 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
0 |
0 |
0 |
0 |
Animal # 447 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
1 |
1 |
1 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
0 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
2 |
2 |
2 |
0 |
Animal # 451 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
0 |
0 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
0 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
0 |
0 |
0 |
0 |
Table 4: GROUP MEAN EYE IRRITATION SCORES
Animal # |
Tissue |
Observation (Hours) |
|||
1 |
24 |
48 |
72 |
||
432 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
2 |
2 |
0 |
0 |
|
Total |
2 |
2 |
0 |
0 |
|
|
|||||
438 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
4 |
4 |
0 |
0 |
|
Total |
4 |
4 |
0 |
0 |
|
|
|||||
442 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
4 |
2 |
0 |
0 |
|
Total |
4 |
2 |
0 |
0 |
|
|
|||||
446 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
0 |
0 |
0 |
0 |
|
Total |
0 |
0 |
0 |
0 |
|
|
|||||
447 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
2 |
2 |
2 |
0 |
|
Total |
2 |
2 |
2 |
0 |
|
|
|||||
451 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
0 |
0 |
0 |
0 |
|
Total |
0 |
0 |
0 |
0 |
|
|
|||||
Group Mean |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva |
2.0 |
1.7 |
0.3 |
0 |
|
Total |
2.0 |
1.7 |
0.3 |
0 |
|
|
Cornea A =density
B =area
Corneal score = (AxBx5)
Maximum score = 80
Iris Iris score = (Ax5)
Maximum score = 10
Conjunctiva A = erythema
B =chemosis
C = discharge
Conjunctival score = (A+B+C) X 2
Maximum score = 20
Total Maximum Score = 110.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Conjunctival irritation was observed in 4/6 of the treated eyes at the 1 hour and 24 hour observation. The maximum group mean irritation score was 2.0/110.0 and occurred at the 1 hour observation. This score decreased to 0 by 72 hours post-instillation. Automate Yellow 8 Petroleum would be classified as Toxicity Category III for eye effects in accordance with EPA regulations. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
- Executive summary:
Automate Yellow 8 Petroleum was instilled into the conjunctival sac of the right eye of six New Zealand Albino rabbits at a dose of 0.1 g. The eyes were observed and scored at 1, 24, 48 and 72 hours after treatment.
Conjunctival irritation was observed in 4/6 of the treated eyes at the 1 hour and 24 hour observations. Conjunctival irritation was observed in 1/6 animals at the 48 hour observation. The maximum group mean score was 2.0/110.0 and occurred at the 1 hour observation. This score decreased to 0 by 72 hours post-instillation.
Therefore, Automate Yellow 8 Petroleum would be classified as Toxicity Category III for eye effects in accordance with EPA regulations.
Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
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