Registration Dossier
Registration Dossier
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EC number: 500-085-9 | CAS number: 35176-06-8 1 - 6.5 moles propoxylated
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD 405, including GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-Iminodiethanol, propoxylated
- EC Number:
- 500-085-9
- EC Name:
- 2,2'-Iminodiethanol, propoxylated
- Cas Number:
- 35176-06-8
- Molecular formula:
- C4H11O2N(C3H6O)n; n = 1 – 6.5
- IUPAC Name:
- 2,2’-Iminodiethanol, propoxylated
- Details on test material:
- Yellowish clear liquid
>99% pure
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Age at study initiation: circa 10 weeks
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
Test system
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1h, 24h, 48h and 72h after application in all 3 animals and on day 7 in 2 animals.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 3 rabbits were dosed with 0.1 mL of Diethanolamine, propoxylated in the conjunctival sac of the right eyelid. Untreated left eyes served as negative control. Rabbits were observed at 1h, 24h, 48h, 72h and 7 days after application, with an otoscope lamp. Assessments were made regarding cornea opacity, affected area, conjunctivae redness, iris, chemosis and discharge. Scoring was based on the criteria of the OECD Harmonized Integrated Classification System.
A check for any dead or moribund animal was made twice each workday and once daily at weekends and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- area involved
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- Application of the test substance resulted in slight redness and chemosis of the conjunctivae, which were fully reversible within 72h.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, classification of Diethanolamine, propoxylated for eye irritation is not warranted.
- Executive summary:
Previous to performing this in vivo eye irritation study, in vitro HET-CAM and BCOP (final report not yet available) assays were performed. In the HET-CAM test Diethanolamine, propoxylated elicited strong irritant effects. However, in the BCOP test, exposure to Diethanolamine, propoxylated did not cause eye irritation. In the in vivo study, 0.1 mL of Diethanolamine, propoxylated was applied to the eyes of 3 female rabbits. Only slight redness (mean score 0.9) and chemosis (mean score 0.7) of the conjunctivae was observed in all animals. This effects was fully reversible after 72h. Based on these results classification of Diethanolamine, propoxylated for eye irritation is not warranted.
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