Registration Dossier
Registration Dossier
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EC number: 939-783-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- ; version September 19, 1984
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diisotridecyl adipate
- EC Number:
- 247-660-8
- EC Name:
- Diisotridecyl adipate
- Cas Number:
- 26401-35-4
- IUPAC Name:
- bis(11-methyldodecyl) adipate
- Details on test material:
- - Name of test material (as cited in study report): Glissofluid A 13
- Physical state: colorless liquid
- Analytical purity: 99.67%
- Lot/batch No.: 18 A/91
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, FRG
- Age at study initiation: adults
- Weight at study initiation: 2.99 - 3.48 kg
- Housing: fully air conditioned rooms; single housing in stainless steel cages with wire mesh walk floors, area 40 cm x 51 cm; no bedding in cages, sawdust in the waste trays
- Diet (e.g. ad libitum): KLIBA Labordiät 341, 4 mm; Klingenthalmühle AG, Kaiseraugst, Switzeland; ca. 130 g per animal and day
- Water (e.g. ad libitum): tap water, ca. 250 mL per animal and day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the test animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to OECD TG 405
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.778
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
Eye irritating effects following a single instillation of 0.1 mL of diisotridecyl adipate to rabbit eyes (grading according to OECD TG 405)
Animal |
Effect |
Score |
|||||
1 h |
24 h |
48 h |
72h |
Mean |
8 d |
||
1 |
Cornea |
0 |
0 |
0 |
0 |
- |
0 |
Iris |
0 |
0 |
0 |
0 |
- |
0 |
|
Conjunctivae |
2 |
1 |
1 |
1 |
1 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
- |
0 |
|
2 |
Cornea |
0 |
0 |
0 |
0 |
- |
SD |
Iris |
0 |
0 |
0 |
0 |
- |
SD |
|
Conjunctivae |
1 |
1 |
0 |
0 |
0.33 |
SD |
|
Chemosis |
0 |
0 |
0 |
0 |
- |
SD |
|
3 |
Cornea |
0 |
0 |
0 |
0 |
- |
SD |
Iris |
0 |
0 |
0 |
0 |
- |
SD |
|
Conjunctivae |
1 |
2 |
1 |
0 |
1 |
SD |
|
Chemosis |
0 |
0 |
0 |
0 |
- |
SD |
|
SD = study discontinued
In general, the irritating effect of diisotridecyl adipate on the rabbit eye was week. No effects at all were seen for cornea, iris, and chemosis. As irritating effect, only conjunctival redness was observed. Mean conjunctivae scores including the 24 to 72 h readings for individual rabbits were 1 or lower.
Rabbit 2 and 3 did not show any effect after 72 h. Thus, the study was discontinued for these animals. For animal 1, all effects had subsided and were absent after 8 days.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Diisotridecyl adipate showed only a very weak response in a primary eye irritation test (only conjunctivae effects grade 1 were observed, fully reversible within 1 to 8 d). Based on the results of this test, diisotridecyl adipate is not irritating to the eye.
- Executive summary:
In a primary eye irritation study, 0.1 mL of diisotridecyl adipate was instilled into the conjunctival sac of one eye of each of 3 adult Vienna White rabbits for 24 hours. Eyes were not washed at the end of the exposure period. Eye irritation was scored 1 h, 24 h, 48 h, 72 h and 8 d after instillation of the test substance using the grading system of OECD test guideline 405 (Acute Eye Irritation/Corrosion). Animals then were observed for 72 h or 8 days dependent on the results of the test.
After treatment, only week effects on conjunctivae could be observed. No reaction was seen for cornea, iris, and chemosis. Conjunctival effects subsided with time and were fully absent after 48 h, 72 h and 8 d for rabbit 2, 3 and 1 respectively.
In this study, diisotridecyl adipate is not irritating to the eye according to EU regulations (Rossbacher/BASF 1992b).
This study is assessed as acceptable. It satisfies the guideline requirements (OECD TG 405) for an acute eye irritation/corrosion study.
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