4,4'-sulfonylbisphenol, polymer with ammonium chloride(NH4Cl), pentachlorophosphorane and phenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 March 2001 - 09 March 2001

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: European Community (EC), Council Directive 67/548/EEC, Annex V, Part B, Methods for the Determination of Toxicity, as last amended by Commission Directive 92/69/EEC, B.5: "Acute Toxicity - Eye Irritation".

Version / remarks:

1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

439-270-3

EC Name:

-

Cas Number:

260408-02-4

Molecular formula:

CAS formula: (C12 H10 O4 S . C6 H6 O . Cl5 P . Cl H4 N)x Molecular formula of the reaction products: (C12 H10 N O2 P)n (n=3-15)

IUPAC Name:

ammonium 4-(4-hydroxybenzenesulfonyl)phenol pentachloro-λ⁵-phosphane phenol chloride

Test material form:

solid: particulate/powder

Details on test material:

Physical Description: White powder
Storage Conditions: At room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: Charles River Deutschland, Kisslegg, Germany.
- Age at study initation: 7-10 weeks old
- Weight at study initation: 1489 - 1859g
- Housing: Individually in labelled cages with perforated floors
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day.
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

53.1 ± 0.9 mg

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

METHOD:
Each animal was treated by instillation of 53.1 ± 0.9 mg of the test substance (a volume of approximately 0.1 ml) in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: According to guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 7 days

Other effects:

Remnants of the test substance were present in the eyes of all animals on day 1.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An eye irritation/corrosion study with SPS-100 in male rabbits was conducted according to OECD 405 and in accordance GLP guidelines. SPS-100 does not have to be classified and has no obligatory labelling requirement for eye irritation.

Executive summary:

An eye irritation/corrosion study with SPS-100 in male rabbits was conducted according to OECD 405 and in accordance with GLP guidelines. Single samples of approximately 53 mg of SPS-100 (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. Instillation of the test substance resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 48 hours in two animals and within 7 days in the other animal. Based on the results,SPS-100 does not have to be classified and has no obligatory labelling requirement for eye irritation.