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EC number: 413-800-3 | CAS number: 87787-81-3 STEPAN TAB -2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 20, 1990 to March 2, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to good laboratory practices, and was well conducted and documented. However, a specific designation of the exact FIFRA or OECD guideline was not given. Also the test material batch number and purity was not specified.
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: guidelines specified by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR) and the OECD Guidelines.
- Deviations:
- no
- Remarks:
- Study report stated there were no deviations.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 87787-81-3
- EC Number:
- 618-070-1
- Cas Number:
- 87787-81-3
- IUPAC Name:
- 87787-81-3
- Reference substance name:
- A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine
- EC Number:
- 413-800-3
- EC Name:
- A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine
- Cas Number:
- 87787-81-3
- Molecular formula:
- C44H79NO3
- IUPAC Name:
- 2-(dioctadecylcarbamoyl)benzoic acid; 2-(ditetradecylcarbamoyl)benzoic acid; 2-[(propan-2-yloxy)carbonyl]benzoic acid; 2-[octadecyl(tetradecyl)carbamoyl]benzoic acid; 2-octadecyl-2,3-dihydro-1H-isoindole-1,3-dione; 2-tetradecyl-2,3-dihydro-1H-isoindole-1,3-dione; benzene-1,2-dicarboxylic acid; dioctadecylamine; ditetradecylamine; octadecyl(tetradecyl)amine
- Reference substance name:
- reaction mass of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid dihydrogenated alkyl (C14-C18)amine
- IUPAC Name:
- reaction mass of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid dihydrogenated alkyl (C14-C18)amine
- Reference substance name:
- Stepan TAB-2
- IUPAC Name:
- Stepan TAB-2
- Details on test material:
- Test material was identified as Stepan Agent X1401-91, an off-white waxy solid. The test sample was stored at room temperature throughout the study in a clear, colorless glass jar with a black plastic lid. The test substance batch number and purity was not noted in the report.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- According to Hilltop Biolabs Inc. procedure, young, healthy adult New Zealand White rabbits (3 males and 3 females) were used. All animals were acclimated to the laboratory for one day before the study. Animals were housed singly in wire mesh suspension cages and fed Purina Laboratory Rabbit Chow or other comparable diet, and tap water ad libitum. The animals were obtained on a 12-hour light/12-hour dark cycle. Cage cards and individual ear marks or tags were used to identify each rabbit.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- The test material was applied at a dose of 0.063 g to one eye of each animal. The other, untreated, eye served as a control.
- Duration of treatment / exposure:
- Exposure was 24 hours after dosing. At the end of 24 hours, the eyes of the animals were rinsed. Fluoroscein staining was utilized for scoring.
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- Six, 3 male and 3 female
- Details on study design:
- The primary ocular irritancy of Stepan Agent X1401-91 was evaluated following the guidelines specified by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR) and the OECD Guidelines.
Young adult, New Zealand White rabbits (3 males and 3 females) were used in this study. The test material was applied at a dose of 0.063 g to one eye of each animal. The eyes of the animals were rinsed after 24 hours. Fluorescein staining was utilized for scoring.
When applicable, the following classification for rating of hazard potential (40 CFR 156, Proposed) was used:
Category I – Corrosive (irreversible destruction of ocular tissue); or corneal involvement or irritation persisting for more than 21 days.
Category II –Corneal involvement or irritation clearing in 8-21 days.
Category III – Corneal involvement or irritation clearing in 7 days or less.
Category IV –Minimal effects clearing in less than 24 hours.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- other: Maximum total irritation scores in individual animals.
- Score:
- 6 - 10
- Max. score:
- 10
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- See tables below
- Other effects:
- The test material produced corneal opacity apparent only at Day 1 and conjunctival irritation, which cleared by Day 10.
Any other information on results incl. tables
Table 1
Primary Eye Irritation in Rabbits Following an Ocular Application of Stepan Agent X1401-91
Animal Number |
Reading |
Corneaa |
Iris |
Conjunctivaa |
Total Scorebc |
|||
A |
B |
|
C |
D |
E |
|||
1-485 |
1 hr |
0 |
0 |
0 |
1F |
1 |
2 |
8 |
|
24 hr |
0/0 |
0/0 |
0 |
1 |
1 |
0 |
4/4 |
|
48 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
72 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
Day 4 |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
Day 7 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
0/0 |
|
Day 10 |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
|
|
|
|
|
|
|
|
|
2-486 |
1 hr |
0 |
0 |
0 |
2F |
1 |
1 |
8 |
|
24 hr |
0/0 |
0/0 |
0 |
1 |
1 |
0 |
4/4 |
|
48 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
72 hr |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 4 |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 7 |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 10 |
0/0 |
0/0 |
0 |
0T |
0 |
0 |
0/0 |
|
|
|
|
|
|
|
|
|
3-387 |
1 hr |
0 |
0 |
0 |
1F |
1 |
1 |
6 |
|
24 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
48 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
72 hr |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 4 |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 7 |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 10 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
0/0 |
aA = Degree of Opacity; B = Area affected; C = erythema; D = Swelling; and E = Discharge.
Table 1 continued
Animal Number |
Reading |
Corneaa |
Iris |
Conjunctivaa |
Total Scorebc |
|||
A |
B |
|
C |
D |
E |
|||
4-499 |
1 hr |
0 |
0 |
0 |
2F |
1 |
2 |
10 |
|
24 hr |
1/1 |
1/1 |
0 |
1 |
1 |
0 |
9/9 |
|
48 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
72 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
Day 4 |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
Day 7 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
0/0 |
|
Day 10 |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
|
|
|
|
|
|
|
|
|
5-500 |
1 hr |
0 |
0 |
0 |
1F |
1 |
1 |
6 |
|
24 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
48 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
72 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
Day 4 |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 7 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
2/2 |
|
Day 10 |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
|
|
|
|
|
|
|
|
|
6-501 |
1 hr |
0 |
0 |
0 |
1F |
1 |
1 |
6 |
|
24 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
48 hr |
0/0 |
0/0 |
0 |
1 |
0 |
0 |
2/2 |
|
72 hr |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 4 |
0/0 |
0/0 |
0 |
1T |
0 |
0 |
2/2 |
|
Day 7 |
0/0 |
0/0 |
0 |
0 |
0 |
0 |
0/0 |
|
Day 10 |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
aA = Degree of Opacity; B = Area affected; C = erythema; D = Swelling; and E = Discharge.
bScoring key appended to report
cTotal Score is the sum of the following three sub-totals, with a maximum score of 110; ( / ) = score without/with sodium fluorescein: 1. Degree of opacity x area involved x 5; 2. Iris score x 5; 3. (Sum of scores for erythema, swelling, and discharge) x 2
F = Blistered appearance to conjunctiva
T = Thickened appearance to conjunctiva.
NA = Not applicable. Animal was not scored due to clearing of irritation at the previous reading.
Applicant's summary and conclusion
- Interpretation of results:
- other: See Conclusions below.
- Remarks:
- Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- The test material was classified in Toxicity Category II (40 CFR 156, proposed) by ocular administration.
- Executive summary:
The primary ocular irritancy of Stepan Agent X1401-91 was evaluated following the guidelines specified by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR) and the OECD Guidelines. The test material produced corneal opacity apparent only at Day 1 and conjunctival irritation which cleared by Day 10, when applied to the eyes of six New Zealand White rabbits. Maximum total irritation scores in individual animals ranged from 6 to 10. No evidence of corrosion was noted.
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