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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:
2002-10-08 to 2002-11-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
,the weights of the animals were not determined at the end of the study.
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2001-09-24

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dithionite
EC Number:
231-890-0
EC Name:
Sodium dithionite
Cas Number:
7775-14-6
Molecular formula:
H2O4S2.2Na
IUPAC Name:
disodium dithionite
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): HYDROSULFIT KONZ. BASF
- Physical state: White powder
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: New Zealand White A1077 INRA (SPF)
- Source: Centre Lago S.A., Vonnas, France
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2.75 kg - 2.93 kg (Individual weights of the three rabbits: 2.77 kg (male), 2.75 (female) and 2.93 kg (female))
- Housing: The animals were individually housed. The animals were housed in fully air-conditioned rooms. Stainless steel wire mesh cages with grating, floor area: 3000 cm^2
- Diet: Kliba-Labordiaet (Provimi Kliba SA, Kaiseraugst, Switzerland), about 130 g/animal per day
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- 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): Each animal received a single application of 0.1 ml bulk volume (about 97 mg of the comminuted test substance) of undiluted test substance into the conjunctival sac of the right eye. The left eye was left untreated and served as negative control.



Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days; Readings of eye irritation at approx. 1, 24, 48 and 72 h after application and then in weekly intervals.
Number of animals or in vitro replicates:
1 male / 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The substance was washed out with tap water.
- Time after start of exposure: About 24 hours after application (before 24 hour reading).

SCORING SYSTEM: Draize scoring system
In addition, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
Area of cornea involved (ar):
1 = >0≤1/4
2 = > 1/4< 1/2
3 = > 1/2 < 3/4
4 = >3/4

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not inlcude small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

ADDITIONAL OBSERVSATION:
It was checked for dead or moribund animals twice each workday (beginning and end) and once on saturdays, sundays and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Moderate or severe conjunctival redness (grade 2 or 3), moderate conjunctival chemosis (grade 2) and slight discharge (grade 1) were observed in all animals 1 hour after application.
Severe conjunctival redness, observed in all animals at the 24-hour reading, persisted in two animals up to 48 hours and decreased to moderate 72 hours after application. In the other animal severe conjunctival redness decreased to slight (grade 1) 7 days after application.
Moderate conjunctival chemosis decreased in two animals to slight (grade 1) 24 hours after application and was seen in one of these animals up to the 72-hour reading. The third animal exhibited moderate conjunctival chemosis at 24 hours which diminished to slight 48 hours after application.
Additionally, circular injected scleral vessels were noted in all animals 1 hour after application, which reduced to a circumscribed area at the 24-hour reading in all animals and persisted up to 48 hours in one animal and up to 72 hours in the other two animals. Moreover, one animal showed a white discoloration at the nictitating membrane 48 and 72 hours after application.
The ocular reactions were reversible in two animals within 7 days and in one animal within 14 days after appplication.
Other effects:
not stated

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance is irritating to the eyes.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 2.