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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
There are no official guidelines for the HET-CAM Test; however, the study was conducted according to the following publications:
- Lüpke N.P. (1985): Hen’s Egg Chorio allantoic Membrane Test for Irritation Potential. Fd. Chem. Toxic. 23, pp. 287 – 291.
- Spielmann, H. (1995): HET-CAM Test. In: Methods in Molecular Biology, 43 (eds.: O’Hare, S. and Atterwill, C. K.) pp. 199 – 204.
- Spielmann, H. et al. (1996): Results of a Validation Study in Germany on Two In Vitro Alternatives to the Draize Eye Irritation Test the HET-CAM Test and the 3T3 NRU Cytotoxicity Test. ATLA 24, pp. 741 – 858.
GLP compliance:
yes

Test material

Constituent 1

Test animals / tissue source

Species:
other: hen eggs
Strain:
other: White Leghorn
Details on test animals or tissues and environmental conditions:
TEST SYSTEM HEN EGG
- Source: Charles River Deutschland GmbH, Extertal
- Age at study initiation: Fresh, fertilized hen eggs
- Weight at study initiation: 55.4 g – 56.9 g

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.5
- Humidity (%): 62.5

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: no control eggs
Amount / concentration applied:
25 µg
Duration of treatment / exposure:
3.5 min
Observation period (in vivo):
3.5 min (210 sec)
Number of animals or in vitro replicates:
Number of eggs: 3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 0.9% aqueous NaCl solution after 3.5 minutes

SCORING SYSTEM:
After application of the test substance the chorionallantoic membrane was observed by means of a stereomicroscope until unambiguous irritation reactions were detected or up to a maximum time period of 3.5 minutes, respectively.
The time of appearance (in seconds after application) of intravascular resp. extravascular coagulation and, if applicable, other reactions (haemorrhagia, vessel lysis) were determined.
The evaluation of the reactions was performed according to the following grading:
Grading
0 - No visible change
1 - Slight reaction
2 - Moderate reaction
3 - Severe reaction
The mean time until appearance of reaction over the eggs of a treatment group was
calculated (mean time to coagulation = mtc in seconds).

TOOL USED TO ASSESS SCORE: stereomicroscope

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: Coagulation
Run / experiment:
1, 2 and 3; observation period 210 seconds
Value:
0
Positive controls validity:
valid
Remarks on result:
other: no indication of serious eye damage
Irritation parameter:
other: haemorrhagia
Run / experiment:
1, 2 and 3; observation period: 210 seconds
Value:
0
Positive controls validity:
valid
Remarks on result:
other: no indication of serious eye damage

Any other information on results incl. tables

Mean results of the positive control substances (2 replicates)
0.1 N NaOH
Grade 2 haemorrhagia after 24 sec
Grade 2 coagulation after 45 sec


1% SDS
Grade 2 haemorrhagia after 38 sec
Grade 2 coagulation after 69 sec

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met