Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
2013
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

Constituent 1
Chemical structure
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
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.