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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloro-2-hydroxypropyl)trimethylammonium chloride
EC Number:
222-048-3
EC Name:
(3-chloro-2-hydroxypropyl)trimethylammonium chloride
Cas Number:
3327-22-8
Molecular formula:
C6H15ClNO.Cl
IUPAC Name:
3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
Details on test material:
Reagens-S-CFZ (CHPT), 65% aqueous solution

65% aqueous solution

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, Herts, UK
- Age at study initiation: 20-24 wk
- Weight at study initiation: 2.2-3.1 kg
- Housing: 1/metal cage with perforated base
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye serves as control
Amount / concentration applied:
Concentration: 65 %
Amount applied: 0.1 ml
Duration of treatment / exposure:
examination after 1 h
Observation period (in vivo):
Examined at 1 h and 1, 2, 3, 4 and 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand torch

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: each of 3 animals
Time point:
other: mean of 24, 48 and 72 h
Score:
<= 1.7
Max. score:
3
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: the most serious effect reported
Irritant / corrosive response data:
Scores for each animal (mean of 24, 48, 72 h)
Corneal scores (max 4): 0/0.3/0
Iridial scores (max 2):0/0/0
conjunctival redness (max 3): 1.7/1.7/1.3
conjunctival chemosis (max 4): 1/1/1

Any other information on results incl. tables

Cornea: 0, 24, 72 h, 48 h: 1 animal: 1, 2 animals: 0,  Iris:
0 (3 animals, 24, 48, 72 h), 
Conjunctiva redness: 24 h: 2 (2 animals), 1 (1 animal)
                     48 h: 2 (3 animals)
                     72 h: 1 (3 animals)
After 4 and 7 days: 0 (3 animals).
Conjunctiva chemosis: 24 h: 2 (1 animal), 1 (2 animals)
                      48 h: 1 (3 animals)
                      72 h: 1 (2 animals), 0 (1 animal)
After 4 and 7 days: 0 (3 animals).

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
A reliable study, conducted according to OECD 405 and GLP, reported transient irritation, particularly of the conjunctiva, from a 65% aqueous solution of CHPTAC, that had resolved by 96 h. The scores would not meet EU criteria for classification.