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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test has been performed following official guidelines, that completely assesses the end point, on a similar substance differing only by the counter ion potassium instead of sodium cation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
4-amino-6-[[4-[[[4-[(2,4-diaminophenyl)azo]phenyl]amino]sulphonyl]phenyl]azo]-5-hydroxy-3-[(4-nitrophenyl)azo]naphthalene-2,7-disulphonic acid, potassium salt
EC Number:
286-384-2
EC Name:
4-amino-6-[[4-[[[4-[(2,4-diaminophenyl)azo]phenyl]amino]sulphonyl]phenyl]azo]-5-hydroxy-3-[(4-nitrophenyl)azo]naphthalene-2,7-disulphonic acid, potassium salt
IUPAC Name:
286-384-2

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
A total of 3 animals were supplied by B&K UNIVERSAL GJ. On arrival at Centro de Investigacion y Desarollo Aplicado SAL the animals weighed 2.0-2.1 kg and were aged approxiamtely 9-10 weeks. Before administration, they were subjected to a preliminary observation and acclimatization period of 7 days. At the start of the study, the aniamls were in perfetc health and the bodyweight was between 2.1-2.3 kg.
The new Zeland White Rabbit was chosen as a test species because it is an animal normally accepted and suitable fpr the study of eye irrittion and there is sufficient background information to justify its use.
Identification
The rabbits were individually identified usign numbered tags, placed on the rabbits ears. The number assigned to each rabbit was stated on the identification card on the cage.

Group size
The substance CARBON DERMA AF 135 was tested on a group of three animals. The number assigned to the animals were 169, 191 and 194.+

Housing
The rabbits were housed individually in stainless steel cages with a grille floor (48x59x37 cm) placed on racks. Each cage was idenitified by a card stating the study code number, animal number and sex, the quantity administered and name or code of the test substance, study director's name, route and animal arrival and administration dates.
Temperature in the animal room was maintained at 17-21°C and the relative humidity was between 45-70%.
Lighting was controlled to provide 12 hours light (7:00 to 19:00 hours) and 12 hours dark per 24-hour period. Throughout the study, the animals had free access to a standard rabbit diet UAR 112 which has been analysed by the manufacturer. Water was supplied ad libitum by an automatic drinking system. The water, supplied by "Compania de Aguas de Sabadell SA" is periodically checked for possible contaminants.

Test system

Vehicle:
water
Controls:
other: the untreated left eye was used as a control
Amount / concentration applied:
The quantity of test substance administered to each animal was 0.1ml, not exceeding a mass of 100 mg.
Duration of treatment / exposure:
The test substance was instilled in a single application.
Observation period (in vivo):
The behaviour of the animals was observed immediately following instilaltion of the test substance and they were then returned to their cages and observed at regular intervals so as not to miss any serious effect of the test substance. The degree of eye irritation was evaluated for each rabbit 1, 24,48 and 72 hours after treatment according to the criteria outlined below. Additional observations were carried oput after 6 days to check the reversibility or irreversibility of the observed reactions.
Number of animals or in vitro replicates:
3 animals
Details on study design:
Both eyes of each animal were examined before treatment in order to reject any animal showing eye alterations. The animal was immobilised and the product was poured into the right conjunctival sac, made perfectly accessible by carefully pulling outwards the lower lid.After application of the test substance, the lids of the treated eye were held closed for a few seconds.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(corneal opacity)
Basis:
animal #1
Time point:
other: mean at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(corneal opacity)
Basis:
animal #2
Time point:
other: mean at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(corneal opacity)
Basis:
animal #3
Time point:
other: mean at 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
(hyperaemia)
Basis:
animal #1
Time point:
other: mean at 24, 48 and 72h
Score:
0.78
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(hyperaemia)
Basis:
animal #2
Time point:
other: mean at 24, 48 and 72 h
Score:
0.78
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
(hyperaemia)
Basis:
animal #3
Time point:
other: mean at 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 d
Irritation parameter:
conjunctivae score
Remarks:
(Edema)
Basis:
animal #1
Time point:
other: mean at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
(edema)
Basis:
animal #2
Time point:
other: mean at 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(edema)
Basis:
animal #3
Time point:
other: mean at 24,48 and 72 h
Score:
0
Max. score:
4
Other effects:
The behaviour and physical condition of the rabbits were normal throughout the study.

Applicant's summary and conclusion

Interpretation of results:
other: not irritant
Conclusions:
The substance was administered for the study of Primary Eye Irritation. After assessment and evalutaion of the alterations caused by the substance, according to OECD 405 and EU B5 it is considered to cause NO IRRITATION to the eye.
Executive summary:

The test substance was administered for the study of primary eye irritation. After assessment and evalutaion of the alterations caused by the substance, according to OECD 405 and EU B5 it is considered to cause NO IRRITATION to the eye.

In the course of the first hour after instillation, the test substance induced in one animal slight swelling (grade 1) of the eyelids and nictating membrane and slightly congestive iris (grade 1). Similarly, all the treated animals presented slight lacrimation. Evaluation of hyperaemia in teh conjunctivae was not possible due to the colouring caused by the product in them.

24hours after treatment, all the animals presented some blood vessels definitely hyperaemic (grade 1) in the conjunctivae, accompanied by slight swelling (grade 1) of the eyelids and nictating membrane in one animal and diffuse areas of opacity in the cornea ( grade 1), affecting at least a quarter of the corneal area in another animal.

In the reading made 48 hours after administration, the observed lesions had remitted and by the end of 72 hours after treatment only one animal continued to present some blood vessels definitely hyperaemic ( grade 1) in the conjunctivae. This lesion had completely disappeared by the addtional reading made 6 days after administration.