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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:
November 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following the guideline without any deviation but not performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
purity > 98%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage du Gérome, France
- Age at study initiation: 12 to 13 weeks
- Weight at study initiation: 2,45 to 2,91 kg
- Housing: individual housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15 volumes per hour
- Photoperiod: 12 hrs dark/ 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0,1 mL pure test item
Duration of treatment / exposure:
One instillation made, then observation during 72h and more if necessary
Observation period (in vivo):
Up to 22 day if effects visible
Number of animals or in vitro replicates:
3 females
Details on study design:
Observations at 1, 24, 48 and 72h were made to determine
- conjunctive chemosis
- conjunctive enanthema
- iris lesion
- corneal opacity
The 4 observation times were suumed for the three animals for determining of the maximal ocular irritation index. (OI max)
The scale is then given:
OI max <= 15 : slightly irritant
15< OI max <= 30 : moderate irritant
30< OI max <= 50 : irritant
50< OI max: very irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1, 24, 48 and 72h
Score:
9.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
Slight conjuntival effects were noted on 3 animals 1 hour after instillation (enanthema slight to moderate with slight chemosis) and were fully reversible within 48h after treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
With a maximum mean irritation score of 9.3, Phosphorous acid, tri-C12-14-alkyl esters was slightly irritant to eyes according to french protocol and scaling but not classified according to GHS criteria.
Executive summary:

Phosphorous acid, tri-C12-14-alkyl esters was tested in vivo for eye irritation using OECD 405 test guideline, but the study was not performed under GLP conditions. No deviation to the guideline was noted and the study was considered as reliable but quoted with reliability 2.

Three New Zealand white rabbits were tested with 0,1 mL pure test item and scoring was performed at 1, 24, 48 and 72 hour.

Slight conjuntival effects were noted on 3 animals 1 hour after instillation (enanthema slight to moderate with slight chemosis) and were fully reversible within 48h after treatment. No other clinical or systemic signs were noted.

With a maximum mean irritation score of 9.3, Phosphorous acid, tri-C12-14-alkyl esters was slightly irritant to eyes according to french protocol and scaling but not classified according to GHS criteria.