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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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.