Registration Dossier
Registration Dossier
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EC number: 200-001-8 | CAS number: 50-00-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Ocular Injury by Transient Formaldehyde Exposure in a Rabbit Eye Model
- Author:
- Lai LJ, Hsu WH, Wu AM, Wu JH
- Year:
- 2 013
- Bibliographic source:
- PLOS ONE (2013) vol. 8; Issue 6
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Eyse of New Zealand White rabbits were exposed to the test substance, Schirmer's test and investigation of cell morphology, death, proliferation and changes of mitochondria
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- CH2O
- IUPAC Name:
- formaldehyde
- Details on test material:
- - Name of test material (as cited in study report): formaldehyde
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Body weight at study initiation: 2.0 - 2.2 kg
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- in vivo: 0, 20, 100, 200, and 300 ppm of 37 % test substance, in vitro: 0, 5, 10, 20, 100, 200, 400, and 600 ppm of 37 % test substance
- Duration of treatment / exposure:
- in vivo: 3 min, in vitro: 3 - 5 min (0 - 600 ppm test substance) or 30 min (100 ppm test substance)
- Observation period (in vivo):
- in vivo: 10 days, in vitro: incubated for 1 and 7 days after exposure
- Duration of post- treatment incubation (in vitro):
- 3 - 30 min
- Number of animals or in vitro replicates:
- 15 (in vivo), 21 (in vitro)
- Details on study design:
- In vivo, the eyes were exposed to small filter discs soaked with 0, 20, 100, 200, or 300 ppm of test substance in water for 5 min. Eyes were washed with BSS. Gentamycin was applied to the eye two times daily. 1, 3, 7 and 10 days after exposure filter strips were introduced into the rabbit’s eye to measure moisture according to the Schirmer’s test. In vitro rabbit corneal cell preparations were exposed to aqueous solutions containing 5 - 600 ppm test substance over 3 - 5 min and cell morphology, death and proliferation were determined as well as changes of mitochondria.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Specific eye scoring
- Remarks on result:
- positive indication of irritation
In vivo
Results
- Irritation parameter:
- other: Specific eye scoring
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- In vivo, tear production was increased at all exposure concentrations and observation times. In vitro, already 5 ppm induced damage to the corneal cells that became apparent only after prolonged observation period. Higher concentrations led to effects already after shorter periods.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Concentrations of 5 ppm lead to eye irritation.
- Executive summary:
In a reliable study, in vivo, the eyes were exposed to small filter discs soaked with 0, 20, 100, 200 or 300 ppm of formaldehyde in water for 5 min. Eyes were washed with BSS. Gentamycin was applied to the eye two times daily. 1, 3, 7 and 10 days after exposure filter strips were introduced into the rabbit’s eye to measure moisture according to the Schirmer’s test. In vitro rabbit corneal cell preparations were exposed to aqueous solutions containing 5 - 600 ppm formaldehyde over 3 - 5 min and cell morphology, death and proliferation were determined as well as changes of mitochondria.
In vivo, tear production was increased at all exposure concentrations and observation times. In vitro, already 5 ppm induced damage to the corneal cells that became apparent only after prolonged observation period. Higher concentrations led to effects already after shorter periods.
These data suggest corrosive properties.
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