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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:
17.01.1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Consumer Product Safety Commission of the USA in the Code of Federal Regulations, Title 16, Section 1500.42.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid
EC Number:
239-931-4
EC Name:
[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid
Cas Number:
15827-60-8
Molecular formula:
C9H28N3O15P5
IUPAC Name:
{[bis({2-[bis(phosphonomethyl)amino]ethyl})amino]methyl}phosphonic acid
Constituent 2
Reference substance name:
[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetraki sphosphonic acid
IUPAC Name:
[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetraki sphosphonic acid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buxted rabbit, Buxted, Sussex, England
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 3.4 kg
- Housing: individually housed in a metal cage with perforated floor
- Diet: Grain Harvester 474 Special rabbit pellets, ad libitum
- Water: tap waterm ad libitum
- Acclimation period: "the rabbit selected for the study were suitably acclimatised to the laboratory environment"

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
NA
Observation period (in vivo):
One hour after instillation
Number of animals or in vitro replicates:
One
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no mention of washing

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: One hour
Score:
4
Max. score:
4
Reversibility:
other: Not investigated, animal euthanised after one hour
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: One hour
Score:
1
Max. score:
2
Reversibility:
other: Not investigated
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: One hour
Reversibility:
not reversible
Remarks on result:
other: Necrosis
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: One hour
Score:
3
Max. score:
4
Reversibility:
other: Not investigated
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: not investigated as severe effects seen at 1 hour observation and the animal was euthanised for welfare reasons.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: not investigated as severe effects seen at 1 hour observation and the animal was euthanised for welfare reasons.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: not investigated as severe effects seen at 1 hour observation and the animal was euthanised for welfare reasons.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: not investigated as severe effects seen at 1 hour observation and the animal was euthanised for welfare reasons.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: not included as severe effects were seen at 1 hour observation in one animal, which was euthanised for welfare reasons.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: not included as severe effects were seen at 1 hour observation in one animal, which was euthanised for welfare reasons.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: not included as severe effects were seen at 1 hour observation in one animal, which was euthanised for welfare reasons.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: not included as severe effects were seen at 1 hour observation in one animal, which was euthanised for welfare reasons.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: not included as severe effects were seen at 1 hour observation in one animal, which was euthanised for welfare reasons.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: not included as severe effects were seen at 1 hour observation in one animal, which was euthanised for welfare reasons.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: not included as severe effects were seen at 1 hour observation in one animal, which was euthanised for welfare reasons.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: not included as severe effects were seen at 1 hour observation in one animal, which was euthanised for welfare reasons.

Any other information on results incl. tables

There was almost instantaneous destruction of the corneal epithelium. This was accompanied by corneal opacification, which over portions of the cornea was severe. Distinct iritis was observed. Well-defined conjunctival swelling with the eye about half closed and necrosis of the nictitating membrane and palpebral and bulbar conjunctivae were observed. The animal was killed one hour after instillation due to the severity of the reactions observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In an eye irritation study (reliability score 2), which was comparable to OECD 405, Dequest 2060s (DTPMP acid) was immediately corrosive to the eye of a rabbit. Additional rabbits were not tested due to the severity of the reaction.