Registration Dossier
Registration Dossier
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EC number: 604-603-5 | CAS number: 147769-93-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.11.98 - 12.01.99
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with an OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- AGEE 623 Amine
- IUPAC Name:
- AGEE 623 Amine
- Reference substance name:
- 108157-52-4
- Cas Number:
- 108157-52-4
- IUPAC Name:
- 108157-52-4
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): AGEE 623 Amine
- Physical state: dark liquid
- Analytical purity: 80.6 %
- Composition of test material, percentage of components: batch contains about 20% solvent
- Lot/batch No.: T29844
- Expiration date of the lot/batch: December 31, 1999
- Storage condition of test material: 4 °C, light protected, in the closed container
- Other:
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg.
- Weight at study initiation: 3.2 kg, 4.8 kg, 3.7 kg
- Housing: Semi-barrier in air conditioned rooms
- Diet (e.g. ad libitum): Free access to Altromirr 2123 maintenance diet rabbit
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 : 12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- The test item was applied in a single dose in the conjunctival sac of one eye
of each animal after pulling the lower Iid away from the eyeball. The Iids
were then gently held together for about 1 second in order to prevent loss of
the material. The untreated eye served as control. - Observation period (in vivo):
- 24 h, 48 h and 72 hour
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: mean of 24h, 48h and 72h
- Score:
- 2.11
- Max. score:
- 2.67
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: mean of 24h, 48h and 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Remarks:
- A
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: mean of 24h, 48h and 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Remarks:
- B
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: mean of 24h, 48h and 72h
- Score:
- 3.44
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the
test item caused marked irritation and corrosive effects to the eyes of albino
rabbits.
According to Directive 93/21 EEC the labelling of the test item (R 41 =risk
of serious darnage to eyes) is required.
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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