Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD guidelines, and is well documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Amount applied per eye is 62 mg instead of recommended 100 mg.
GLP compliance:
no
Remarks:
Study was undertaken before GLP guidelines were in place.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: TPAB
- Chemical name: Tetra-n-propylammonium bromide
- CAS no.: 1941-30-6
- Substance type: hygroscopic crystalline powder
- Solubility: water, ethanol
- Melting point: 260-270°C
- Storage condition of test material: at ambient temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 4 to 5 months
- Weight at study initiation: 2639-2770 g
- Housing: individually housed
- Diet: standard laboratory animal diet (Hope Farms, Woerden: LK-01, pellet diameter 4 mm); 100g per day
- Water: tap water, ad libitum
- Acclimation period: 6 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 50-80
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01-04-1986 To: 15-04-1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 62 mg (correlates to 1 ml with bulk density = 0.62 g/ml)

Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: According to guideline, observation times: 1, 24, 48 and 72 hours, and 7 and 14 days after instillation.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
1.56
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
One hour after instillation conjunctival redness and swelling was present in all three animals. The erythema intensified in the next 24 hours, and could still be observed 7 days after dosing, particularly on the nictitating membrane. At 7 days after instillation, the chemosis had completely disappeared in all three rabbits. The conjunctival effects were completely reversible within 14 days. Adverse effects on the cornea and iris were not observed in any of the rabbits during the entire observation time.
Other effects:
During the first day after dosing a slightly elevated amount of discharge was observed in all rabbits, which persisted the next day for 2/3 animals. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage. Signs of systemic intoxication were not observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An eye irritation test was performed according to OECD guideline 405. TPAB was not irritating to the rabbit's eye.
Executive summary:

An eye irritation test was performed according to OECD guideline 405. All three animals had conjunctival redness at 24 hours, which was completely reversible within 14 days. At 7 days after instillation, the chemosis had completely disappeared in all three rabbits. Adverse effects on the cornea and iris were not observed in any of the rabbits during the entire observation time. Based on these results, it can be concluded that TPAB is not irritating to the eye and is not classified according to EC guideline No. 1272/ 2008.