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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
In vivo. Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 June 2010 - 5 Ocotober 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium pyrophosphate
EC Number:
231-767-1
EC Name:
Tetrasodium pyrophosphate
Cas Number:
7722-88-5
Molecular formula:
H4O7P2.4Na
IUPAC Name:
tetrasodium (phosphonatooxy)phosphonate
Details on test material:
- Name of test material (as cited in study report): tetrasodium pyrophosphate
- Physical state: solid
- Analytical purity: 98%
- Purity test date: 08/2011
- Lot/batch No.: 449/09

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Loughborough, UK
- Weight at study initiation: 2.02 kg
- Housing:Suspended cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 95 mg (as measured by gently compacting the required volume into an adapted syringe)
Duration of treatment / exposure:
Once
Observation period (in vivo):
4 hours - after which the animal was euthanized.
Number of animals or in vitro replicates:
1
Details on study design:


SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour following treatment, according to the numerical evaluation (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Any other ocular effects were also noted.



TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Any clinical signs of toxicity, if present, were also recorded.

The animal’s bodyweight was recorded on Day 0 (the day of dosing).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hr
Score:
1
Max. score:
4
Remarks on result:
other: Exposure to the test material for 1 hour only due to severe reactions
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hr
Score:
1
Max. score:
2
Remarks on result:
other: Exposure to the test material for 1 hour only due to severe reactions
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 hr
Score:
3
Max. score:
3
Remarks on result:
other: Haemorrhage of the nictitating membrane and upper and lower conjunctival membrane observed. Exposure to the test material for 1 hour only due to severe reactions
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1hr
Score:
2
Max. score:
4
Remarks on result:
other: Exposure to the test material for 1 hour only due to severe reactions
Irritant / corrosive response data:
Scattered or diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation were noted in the treated eye one hour after treatment. Haemorrhage of the nictitating membrane and upper and lower conjunctival membrane were also noted in the treated eye at this observation. Blood stained discharge was also observed on the day of dosing.
Due to severe bleeding of the eye the animal was killed for humane reasons, on the day of dosing, in accordance with Company policy and current UK Home Office guidelines.

Any other information on results incl. tables

Individual and Total Scoresfor Ocular Irritation

Rabbit Number and Sex

69566Male K*

IPR= 3

Time After Treatment

1 Hour

CORNEA

 

E = Degree of Opacity

1

F = Area of Cornea Involved

4

Score (E x F) x 5

20

IRIS

 

D

1

Score (D x 5)

5

CONJUNCTIVA

 

A = Redness

3H

B = Chemosis

2

C = Discharge

2

Score (A + B + C) x 2

14

Total Score

39



 

IPR=  Initial pain reaction

H =      Haemorrhage of the nictitating membrane and upper and lower conjunctival membrane

K =     Animal killed for humane reasons in accordance with Company policy and current UK Home Office guidelines due to severe bleeding of the eye

*=       Blood stained discharge observed prior to death

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Substance was considered to cause irreversible effects on the eye of 1 rabbit. The reaction was so severe that the test animal had to be euthanized 4 hours post-administration. Therefore in accordance with Regulation (EC) No. 1272/2008 (EU CLP) tetrasodium pyrophosphate is considered to cause serious and irreversible effects on the eye.
This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation EC (No.) 1272/2008 (EU CLP).