Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
March 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP compliant, the subsatance is salified with ammonium salt instead than sodium

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: REAL DECRETO 363/1995, 10 march
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:authorized supplier.
- Weight at study initiation:2341-2454g
- Housing:Housing: Stainless steel single cage
- Diet : daily dose of 150 g experimental diet for rabbits, provided by an authorized vendor
- Water :filtered tap water (5 µm) , ad libitum
- Acclimation period:7 days
- Health check: during observation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2°C
- Humidity (%):55 ± 25%
- Air changes (per hr):15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod : 12 hour cycle dark/light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1,24,48,72 hours and 7,14,21 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM:cornea, iris, conjunctiva, (edema) Chemosis

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0.22
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0.775
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0.22
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The tested substance is classified not irritant for eyes
Executive summary:

Direct Brown 44 ammonium salt has been tested for eye irritation with 3 New Zealand white rabbits according to Royal decree 363/1995 . After 72 hours of observation no rabbits show any signs of damage. The substance is classified as non-irritating to the eyes.