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EC number: 700-934-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritant
Eye irritation: irritant due to redness, chemosis and corneal opacity
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 06, 2007 to November 17, 2007 (experimental)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Chbb:HM (russian)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißleg
- Age at study initiation: 17 to 35 months
- Weight at study initiation: 2.7 – 2.8 kg
- Housing: individually in PPO cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3
- Humidity (%): up to 70
- Air changes (per hr): 10
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: Nov 06, 2007 To: Nov 17, 2007 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied. 0.5 mL/animal - Duration of treatment / exposure:
- 3 min, 1 hour, 4 hours as preliminary assessment
4 hours in three main study aniamls - Observation period:
- Skin reactions were recorded: after 1, 4, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: adhesive Gothaplast
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hours
SCORING SYSTEM: Scoring system based on Draize
Erythema and eschar formation:
- No erythema 0
- Very slight erythema (barely perceptible) 1
- Well-defined erythema 2
- Moderate to severe erythema 3
- Severe erythema (beet redness) to
eschar formation preventing grading
of erythema 4
-- Total possible erythema score 4
Edema formation:
- No edema 0
- Very slight edema (barely perceptible) 1
- Slight edema (edges of area well defined
by definite raising 2
- Moderate edema (raised approx. 1mm) 3
- Severe edema (raised more than 1 mm and
extending beyond the area of exposure 4
-- Total possible edema score 4 - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not irritating to skin of rabbits and thus, is not subject of classification.
- Executive summary:
Skin irritation test in rabbits, according to OECD guideline 404, with three rabbits. Potential skin irritating properties were investigated on the intact skin (semiocclusive). The test item did not provoke any signs of oedema or erythema at any point of time.
Reference
Table for results of skin irritation study
score (average of 3 animals investigated) |
time |
Erythema |
Edema |
average score |
1 h |
0.0 |
0.0 |
24 h |
0.0 |
0.0 |
|
48 h |
0.0 |
0.0 |
|
72 h |
0.0 |
0.0 |
|
average score |
24h, 48 and 72h |
0.0 |
0.0 |
reversibility: * |
n.a. |
n.a. |
|
average time for reversibility |
n.a. |
n.a. |
|
n.a. : not applicable |
|||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 19, 2007 to December 19, 2007 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Russian, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißleg
- Age at study initiation: 33 - 36 months
- Weight at study initiation: 2.7-2.9 kg
- Housing: Individually in PPO cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (12 hrs dark / 12 hrs light):
IN-LIFE DATES: From November 10, 2007 to December 19, 2007 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one eye was treated, the other one served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- Exposure was 24 hours. At this time, fluorescein was instilled and irrigated with 20 mL of a 0.9% of sodium chloride solution.
- Observation period (in vivo):
- 21 days; Eye examinations were performed at 1, 24, 48 and72 hours and on Days 7, 14 and 21
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: Cornea
A) Opacity degree of density
No ulceration or opacity: 0
Scattered or diffuse area of opacity: 1
Easily discernable translucent areas: 2
Nacreous areas; no details of iris visible: 3
Complete corneal opacity, iris not discernable: 4
B) Extent of effected area
More than 0 but less than ¼: 1
More than ¼ but less than ½: 2
More than ½ but less than ¾: 3
More than ¾ to whole area: 4
Iris
Normal: 0
Markedly deepened folds and/or
congestion, swelling, moderate circumcorneal
injection but still shows (even delayed) reaction: 1
No reaction to light, hemorrhage, gross destruction: 2
Conjunctiva
A) Reddening
Blood vessels normal: 0
Blood vessels definitely injected: 1
Diffuse crimson red, individual vessels not
easily discernible: 2
Diffuse beefy red: 3
B) Chemosis
No swelling: 0
Swelling above normal
(includes nicitating membrane): 1
Obvious swelling with partial eversion of the lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
C) Discharge
No discharge: 0
Any amount different from normal
(excluding normal secretion of healthy animals): 1
Discharge with moistening of lids: 2
Discharge with moistening of a wide area
around the eye:
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Slight to well defined changes were found in the cornea, iris and conjunctiva such as scattered or diffuse opacity, markedly deepened rugae, congestion, swelling and moderate circumcorneal hyperemia of the iris and diffuse crimson color as well as obvious swelling and with partial eversion of eyelids, as far as the conjunctivae were concerned.
Findings were near to equal at 24 and 48 hours, but declined slightly after 72 hours. Changes of the cornea were reversible after 14 days and after 7 day in the other eye structures. - Other effects:
- Slight lacrimation
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The Test Substance is classified to be Irritating to eyes under the conditions of the test.
- Executive summary:
The local eye irritating potential of TPI 1618 was investigated according to OECD 405 (2002) which equals Commission Directive 2004/73/EC B.5. TPI 1618 was found to be irritating to the eyes of rabbits. Maximal revovry period was 14 days.
Reference
Table: Results of eye irritation
Results of eye irritation study |
Cornea |
Iris |
Conjunctiva |
|
redness |
chemosis |
|||
score (range from 0 to maximum score) |
0 to 4 |
0 to 2 |
0 to 3 |
0 to 4 |
60 min |
0 |
0 |
1 |
1 |
24 h |
1 |
1 |
2 |
2 |
48 h |
1.3 |
0.7 |
2 |
1.7 |
72 h |
1.3 |
0.3 |
1.6 |
1.3 |
Day 7 |
0.3* |
0 |
0 |
0 |
Day 14 |
0.3* |
0 |
0 |
0 |
Day 21 |
0 |
0 |
0 |
0 |
Average 24h, 48h, 72h |
1.2 (1.4*) |
0.8 |
1.9 |
1.7 |
Cornea, area effected 1 h |
0 |
|
|
|
Maximum average score |
1.3 |
0.7 |
2 |
1.7 |
Reversibility |
c |
c |
c |
c |
average time for reversion |
14 days |
7 days |
7 days |
7 days |
Give method of calculation maximum average score. |
||||
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
EUF was tested undiluted for primary skin reactions. In the most recently performed study (from 2008), no signs of irritation were observed. Therefore, no classification is required for skin irritation
In an eye irritation study (2008), EUF induced eye irritations, which were most likely due to the irritating properties of formaldehyde. No such effects can be expected from either ethylene glycol or urea respectively.
Effects on eye irritation: irritating
Justification for classification or non-classification
EUF induced corneal opacity as well as redness and chemosis of the conjunctiva. Proposal for classification and labelling of EUF according to Directive (EG) 1272/2008:
Signal Word: Warning, Hazard Statement: H319 – irritating to eyes (Cat. 2A).
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