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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratory, Portage, MI
- Age at study initiation: Approximately 8 weeks (young adults)
- Weight at study initiation: 230-264 grams (males) and 166-200 grams (females)
- Fasting period before study: fasted overnight prior to test material administration
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum, except for overnight fasting prior to dosing. Purina Laboratory Rodent Chow (Registered Trademark of the Ralston-Purina Company, St. Louis, Missouri) was used.
- Water (e.g. ad libitum): ad libitum, except for overnight fasting prior to dosing. Water was furnished by the City of St. Louis, Missouri.
- Acclimation period: at least five days
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): The test material was administered as a 372 mg/mL suspension in corn oil. The volume administered was adjusted according to body weight and the dosage to be given.
Doses:
1984, 2500, 3150, 3969 and 5000 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for death and overt signs of toxicity were made three times within the first eight hours after dosing and twice daily (morning and afternoon) thereafter. Body weights were recorded on days 0 (day of dosing), 7, and 14.
- Necropsy of survivors performed: yes (After 15 days on test, the surviving animals were sacrificed. Necropsies were performed on all animals.)
Statistics:
The acute oral LD50 for each sex and for the combined sexes was calculated using the method of Finney [Finney, D.J., (1971). Probit Analysis (3rd edition). Cambridge University Press].
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 604 mg/kg bw
95% CL:
>= 2 247 - <= 2 940
Remarks on result:
other: Slope: 9.3
Remarks:
95 % Confidence Limits: 4.7 and 13.8
Sex:
male
Dose descriptor:
LD50
Effect level:
2 925 mg/kg bw
95% CL:
>= 2 414 - <= 3 518
Remarks on result:
other: Slope 11.2
Remarks:
95 % Confidence Limits: 3.9 and 18.5
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
2 304 mg/kg bw
95% CL:
>= 1 421 - <= 2 790
Remarks on result:
other: Slope. 9.4
Remarks:
95 % Confidence Limits: 1.8 and 17.0
Clinical signs:
Toxicity to the nervous system was suggested by several of the clinical abnormalities that were observed during the early part of this study. Sedation, ptosis, and ataxia were each observed in at least 12 animals by the first day after dosing and each occurred in a dosage-related manner. Prostration and lacrimation also occurred, but these abnormalities were observed in fewer animals. Gastrointestinal involvement was indicated by diarrhea, but this may have been induced by the corn oil used as the dosing vehicle.
Gross pathology:
Necropsy findings of gastrointestinal (GI) distension, discoloration of the intestines, and apparent gastrointestinal hemorrhage indicated that the GI tract was affected by this test material.

Acute Oral Toxicity to Rats Mean Body Weight and Mortality Summary

Dosage (mg/kg)

Mean body weight (Grams)

N° deaths / N° dosed

Days of death postdosing

Day 0

Day 7

Day 14

Male rats

1984

247

301

352

0/5

-

2500

248

282

334

2/5

2,2

3150

251

278

326

2/5

1,2

3969

248

-

-

5/5

1,1,2,2,3

5000

238

-

-

5/5

1,2,2,2,2

Female rats

1984

181

210

235

1/5

1

2500

186

221

247

4/5

1,2,2,2

3150

179

209

228

4/5

1,2,2,2

3969

179

-

-

5/5

1,1,2,2,2

5000

174

-

-

5/5

1,1,1,2,2

Table 2
Acute Oral Toxicity to Rats Summary of Observations During Life
Observation Dosage (mg/kg) No. Observed/No. Dosed*  
Male Female Combined Comments
Sedation
1984 1/5 0/5 1/10 Day 0 only
2500 3/5 3/5 6/10 Days 1, 2, and 5
3150 2/5 3/5 5/10 Days 1, 2, and 5
3969 5/5 5/5 10/10 Days 0 thourgh 2
5000 4/5 5/5 9/10 Day 1 only
Ataxia
2500 2/5 0/5 2/10 Days 1 and 2
3150 1/5 1/5 2/10 Days 1 and 2
3969 1/5 4/5 O/J.0 Days 1 and 2
5000 1/5 3/5 4/10 Day 1 only
Prostration
3150 0/5 2/5 2/10 Day 1 only
3969 2/5 1/5 3/10 Day 1 only
5000 0/5 1/5 1/10 Day 1 only
Ptosis
2500 2/5 0/5 2/10 Days 1 and 2
3150 2/5 3/5 5/10 Days 1 and 2
3969 4/5 5/5 9/10 Days 0 through 2
5000 4/5 4/5 8/10 Day 1 only
Lacrimation
2500 0/5 1/5 1/10 Day 1 only
3150 0/5 3/5 3/10 Day 1 only
3969 2/5 0/5 2/10 Day 1 only
Diarrhea
1984 0/5 1/5 1/10 Day 1 only
2500 4/5 1/5 5/10 Days 1 and 2
3150 4/5 3/5 7/10 Days 1 and 2
3969 5/5 5/5 10/10 Day 1 only
5000 5/5 3/5 8/10 Day 1 only
Lack of Feces
3150 2/5 1/5 3/10 Days 1 and 2
3969 1/5 0/5 1/10 Day 2 only
Chromodacryorrhea
2500 2/5 0/5 2/10 Days 1 and 2
3969 1/5 0/5 1/10 Day 2 only
5000 2/5 0/5 2/10 Day 1 only
Porphyrin Around the Nose
2500 1/5 1/5 2/10 Days 1 and 2
3150 2/5 0/5 2/10 Day 2 only
3969 2/5 2/5 4/10 Days 1 and 2
5000 1/5 1/5 2/10 Day 1 only
Piloerection
3969 0/5 1/5 1/10 Day 1 only
Dark (Purple) Coloration of the Tail
2500 1/5 0/5 1/10 Day 1 only
Incomplete Administration ("Bakflush) of Test Material
3969 Ö/5 i/s 1/10 Day 0 only
*For the number of -living animals during the observation periods listed above, refer to Table 1.

Table 3
Acute Oral Toxicity to Rats Summary of Necropsy Observations
Observation Dosaqe (mg/kg) No. Observed/No. Dosed
Male Female Combined
Gastrointestinal Distension
1984 0/5 1/5 1/10
2500 1/5 2/5 3/10
3150 1/5 1/5 2/10
3969 3/5 1/5 4/10
5000 3/5 3/5 6/10
Dark and/or Red Discoloration of the Intestinal Tract
1984 0/5 1/5 1/10
2500 1/5 1/5 2/10
3150 1/5 2/5 3/10
3969 4/5 3/5 7/10
5000 3/5 4/5 7/10
Apparent Gastrointestinal Hemorrhage
5000 0/5 2/5 2/10
Urine Stained Fur
1984 0/5 1/5 1/10
2500 2/5 2/5 4/10
3150 2/5 2/5 4/10
3969 3/5 3/5 6/10
5000 4/5 5/5 9/10
Diarrheal Feces or Feces Stained Fur
1984 0/5 1/5 1/10
2500 2/5 1/5 3/10
3150 2/5 1/5 3/10
3969 4/5 3/5 7/10
5000 5/5 1/5 6/10
Lacrimation
1984 0/5 1/5 1/10
Excessive Salivation
3969 0/5 1/5 1/10
5000 0/5 1/5 1/10
Red Discharge from the Nose and/or the Eyes
1984 0/5 1/5 1/10
2500 1/5 2/5 3/10
3150 1/5 1/5 2/10
3969 2/5 3/5 5/10
5000 3/5 3/5 6/10
Red Material on the Forelegs (Apparently Rubbed off the Face)
2500 0/5 1/5 1/10
Pale Coloration of the Liver
1984 0/5 1/5 1/10
Autolysis of Internal Tissues
2500 1/5 2/5 3/10
3150 1/5 3/5 4/10
3969 1/5 3/5 4/10
5000 2/5 1/5 3/10
Interpretation of results:
not classified
Conclusions:
The acute oral LD50 was calculated to be 2604 mg/kg bw with 95% CL of 2247 -2940 mg/kg.
For male rats, the acute oral LD50 was calculated to be 2925 mg/kg.
For female rates, it was calculated to be 2304 mg/kg bw.
Executive summary:

When the test item (Toluene soluble terphenyl and quarterphenyls) was administered to fasted albino rats of both sexes, the acute oral LD50 was calculated to be 2604 mg/kg bw with 95% CL of 2247 -2940 mg/kg. For male rats, the acute oral LD50 was calculated to be 2925 mg/kg, and for female rates, it was calculated to be 2304 mg/kg bw. Observations considered to be treatment related included sedation, ptosis, ataxia, prostration, lacrimation, and diarrhoea. Necropsy findings indicated that the gastrointestinal tract was affected.

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: approximately 10 weeks (young adults)
- Weight at study initiation: 2.42 - 2.80 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum. Purina Rabbit Chow (Registered Trademark of the Ralston-Purina Company, St. Louis, Missouri) will be used.
- Water (e.g. ad libitum): ad libitum. Water will be furnished by the City of St. Louis, Missouri.
- Acclimation period: at least five days
Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: the dorsal surface
- % coverage: 10-30% of total body surface
- Type of wrap if used: The test material was held in place by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The excess material was wiped from the animal.
- Time after start of exposure: The occlusive wrap was removed after approximately 24 hours
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals per dose per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for death and overt signs of toxicity were made three times during the first eight hours following test material administration and twice daily (morning and afternoon) thereafter. Body weights were recorded on days 0 (day of dosing), 7, and 14.
- Necropsy of survivors performed: yes (after 15 days on test, all animals were sacrificed and necropsies were perfromed on all animals)
Statistics:
The acute dermal LD50 for each sex and for the combined sexes was calculated using the method of Finney [Finney, D.J., (1971). Probit Analysis (3rd edition). Cambridge University Press].
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths were observed in animals of either sex.
Clinical signs:
All clinical abnormalities observed during this study were considered to result from direct contact between the test material and the skin in the exposed area. Erythema of the skin occurred in nine animals. The duration of this effect ranged from two to thirteen days in individual, affected animals. Edema of the skin was observed in one female and two male animals on the first day after test material administration. Areas of inhibited growth of fur occurred in one female and two male animals and were observed on the last three days of the study.
Gross pathology:
At necropsy, most of the findings reflected the effect of direct contact of the skin in the exposed area with the test material. Redness of the skin was observed in two male and three female animals. Areas of inhibited fur growth occurred in one male and two female rabbits. Hardened skin was observed in one male animal. Raised skin occurred in one female animal. One animal of each sex had defatted skin. Both kidneys of one male animal had pitted exteriors, but this was not considered to represent toxicity of the test material.

Acute Dermal Toxicity to Rabbits Mean Body Weight and Mortality Summary

Dosage (mg/kg)

Mean body weight (Kg)

N° deaths / N° dosed

Days of death postdosing

Day 0

Day 7

Day 14

Male rats

5000

2.58

2.78

3.00

0/5

-

Female rats

5000

2.62

2.78

3.03

0/5

-

Interpretation of results:
not classified
Conclusions:
The acute dermal LD50 for MCS-1980 was determined to be above 5000 mg/kg bw.
Executive summary:

No deaths followed a dermal application of 5000 mg/kg bw of Toluene soluble terphenyl and quarterphenyls to the shaved and abraded dorsal surface of albino of both sexes. Therefore, the acute dermal LD50 of this material is considered to be in excess of 5000 mg/kg bw. Clinical abnormalities included erythema, edema, and inhibited growth of fur in the exposed area.

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Draize, J. H., Woodard, G., and Calvery, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Thera p. 82: 377-390.
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: Approximately 10 weeks (young adults)
- Weight at study initiation: 2.16-2.60 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (Purina Rabbit Chow® (Registered Trademark of the Ralston-Purina Company, St, Louis, Missouri))
- Water (e.g. ad libitum): ad libitum (water furnished by the City of St. Louis, Missouri)
- Acclimation period: at least five days
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 0.5 ± 0.009 grams of the test material
Duration of treatment / exposure:
single exposure, 24 h exposure
Observation period:
The initial (day one) observation for skin irritation was made approximately one hour after the removal of the wrappings. Results were recorded at 24 and 72 hours after topical application. The animal that had irritation present during the 72 hour examination was also observed for signs of irritation on the seventh and tenth days after exposure.
Number of animals:
3 animals per sex
Details on study design:
TEST SITE
- Area of exposure: dorsal surface
- % coverage: The test material was applied to the skin under one inch square gauze patches
- Type of wrap if used: wrap of latex rubber secured by bandaging and elastic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was wiped from the treated sites of the animals
- Time after start of exposure: aproximately 24 hours

SCORING SYSTEM: Dermal irritation was scored by the method of Draize (1944)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Intact and abraded skin
Remarks:
48 h value was not evaluted.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Intact skin
Remarks:
48 h value was not evaluted.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.13
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Abraded skin
Remarks:
48 h value was not evaluted.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks:
.
Remarks on result:
other: Intact and abraded skin
Remarks:
48 h value was not evaluted.
Irritant / corrosive response data:
All skin irritation had subsided by the tenth day after test material administration. Defatting of the skin on all four exposed sites occurred in one animal on the tenth day after exposure. No signs of systemic toxicity were observed.

The daily individual, daily, mean, and 24- and 72 hour average Draize scores for the six animals are summarized below.

The Primary Irritation Index for this group of animals is 0.1 on a scale of 0.0 to 8.0. All skin irritation had subsided by the tenth day after test material administration. Defatting of the skin on all four exposed sites occurred in one animal on the tenth day after exposure. No signs of systemic toxicity were observed.

Table 1
Primary Skin Irritation to Rabbits Individual Irritation Scores

Animal Number

Period (Days)

ERYTHEMA

EDEMA

RFI

LBI

LFA

RBA

RFI

LBI

LFA

RBA

01M01

1

0

0

0

0

0

0

0

0

01M02

1

0

0

0

0

0

0

0

0

01M03

1

V

0

0

0

0

0

0

01F01

1

0

0

0

0

0

0

0

0

01F02

1

0

0

0

0

0

0

0

0

01F03

1

0

0

0

1

0

0

0

0

01M01

3

1

1

1

1

0

0

0

0

01M02

3

0

0

0

0

0

0

0

0

01M03

3

0

0

0

0

0

0

0

0

01F01

3

0

0

0

0

0

0

0

0

01F02

3

0

0

0

0

0

0

0

0

01F03

3

0

0

0

0

0

0

0

0

01M01

7

1

1

1

1

0

0

0

0

01M01

10

0

0

0

 0

0

0

0

0

RFI - Right Front Intact Patch

RBA - Right Back Abraded Patch

LBI - Left Back Intact Patch

LFA - Left Front Abraded Patch

Primary skin irritation score summary:

Period (days)

Erythema

Edema

Irritation score

Intact

Abraded

Mean

Intact

Abraded

Mean

1

0.0

0.1

0.0

0.0

0.0

0.0

0.0

3

0.2

0.2

0.2

0.0

0.0

0.0

0.2

Interpretation of results:
not irritating
Conclusions:
The key study for skin irritation/corrosion is a K1 GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5 g of the test material for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed.
Executive summary:

The key study for skin irritation/corrosion is a K1 GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5 g of the test material for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed. A primary Irritation Index of 0.1 on a scale of 0.0 to 8.0 was calculated following continous 24 -hour dermal exposure of the intact and abraded skin of six rabbits to the test item. All skin irritation had subsided by the tenth day after test material (Toluene soluble terphenyl and quarterphenyls) administration.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Draize, J. H., Woodard, G., and Calvery, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Thera p. 82: 377-390.
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Terphenyl
EC Number:
247-477-3
EC Name:
Terphenyl
Cas Number:
26140-60-3
Molecular formula:
C18H14
IUPAC Name:
terphenyl
Details on test material:
- Name of test material: Toluene soluble terphenyl and quarterphenyls
- Physical state: brown solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: Approximately 10 weeks ( young adults)
- Weight at study initiation: 2.14-2.63 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (Purina Rabbit Chow O (Registered Trademark of the Ralston-Purina Company, St. Louis, Missouri))
- Water (e.g. ad libitum): ad libitum (water furnished by the City of St. Louis, Missouri)
- Acclimation period: at least five days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 76 ± 2 mg determined to occupy a volume of 0.1 mL of test material
Duration of treatment / exposure:
single administration
Observation period (in vivo):
Signs of irritation were recorded on the first, second, and third days after dosing.
Number of animals or in vitro replicates:
3 animals per sex
Details on study design:
SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.6
Max. score:
110
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
< 0.2
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
< 0.2
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
5
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: not specified
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.

Any other information on results incl. tables

The individual and the 24, 48, and 72 hour average Draize scores for the six rabbit eyes treated with the test item are summarized below.

The average Draize score for this group of animals is 0.6 on a scale of 0 to 110. All irritation had subsided by the second day after exposure.

Primary Eye Irritation to Rabbits Individual Irritation Scores

Animal n°

Obs. day

Cornea

Iris

Conjunctivae

Total

Average of 24, 48, 72 h

01M01

1

5

0

0

5

1.7

2

0

0

0

0

3

0

0

0

0

01M02

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

01M03

1

0

0

2

2

0.7

2

0

0

0

0

3

0

0

0

0

01F02

1

0

0

4

4

1.3

2

0

0

0

0

3

0

0

0

0

01F02

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

01F03

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
This key study for eye irritation is performed according to GLP and similar to OECD guideline 405, in which the Draize scoring system is used. New Zealand White rabbits were exposed to a single dose of 76 mg of the toluene soluble terphenyl and quarterphenyl test substance via the eye. Signs of irritation were recorded on the first, second and third day after dosing. Only on the first day signs of irritation were noted in 3 of the 6 test animals. By day 2, all animals were free of irritation signs.
Executive summary:

When 76 mg (the 0.1 mL equivalent) of the test item (Toluene soluble terphenyl and quarterphenyls) was instilled into the conjunctival sac of the albino rabbit eye, the average of the Draize scores for 24, 48, and 72 hours was 0.6 on a scale of 0 to 110 for six eyes. All irritation had susided by the second day after exposure.