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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
Study period:
11.05.1995 to 15.05.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.90 to 3.12 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 48-55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 11.05.1995 to 15.05.1995

Test system

Vehicle:
other: aqueous solution, administered undiluted.
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
NA
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
After consideration of the ocular responses produced in the first animal, two additional animals were tested. These animals received one drop of local anaesthetic to minimise pain.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Score:
6.7
Reversibility:
fully reversible
Irritant / corrosive response data:
See below
Other effects:
None

Any other information on results incl. tables

CORNEA
No scored effects.  Total score 0.

IRIS
No scored effects.  Total score 0.


CONJUCTIVAL REDNESS
1 hour       1,1,2
24 hours    1,0,1
48, 72 hours   0,0,0
Total score 6.  

CONJUNCTIVAL CHEMOSIS
1 hour   1,1,1
24, 48, 72 hours   0,0,0
Total score 3.

CONJUNCTIVAL DISCHARGE
1 hour   1,1,1
24, 48, 72 hours   0,0,0
Total score 3.

Maximum group mean score = 6.7.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study conducted to OECD 405 and to GLP (reliability score 1) sodium salt of HEDP was not irritating to the eyes of rabbits. There wer minimal conjunctival effects at the one hour time interval, but these were not sufficient to trigger classification.