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Registration Dossier
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EC number: 915-589-8 | CAS number: -
Toxicological information
Endpoint summary
Administrative data
Description of key information
Skin irritation (FIFRA, TSCA), rabbit: irritating
Eye irritation (FIFRA, TSCA), rabbit: not irritating
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:
- Jan 20, 1986 - Feb 25, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (US EPA)
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA (US EPA)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species: New Zealand White, albino rabbits
- Source: Hazleton-Dutchland, Inc.; Denver, Pennsylvania
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel cages
- Diet: Lab Rabbit Chow HF, ad libitum:
- Water: ad libitum
- Acclimation period: 22 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 16°C - 21°C (60 - 70°F)
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- other: see below
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml (undiluted) per site - Duration of treatment / exposure:
- Single 4- or 24-hour exposure
- Observation period:
- 3-14 d
- Number of animals:
- 6 (2 males, 4 females)
- Details on study design:
- TEST SITE
The test material was applied to four intact sites on each animal.
Two sites were semi-occluded, two sites were occluded for 24 h.
Exposure period: Two sites for 4 h, two sites for 24 h
ADMINISTRATION OF TEST MATERIAL
- 4-h exposure, semi-occlusive
- 24-h exposure, occlusive
SCORING SYSTEM:
All sites were evaluated for erythrema, edema and other evidence of dermal irritation according to the DRAIZE scoring system.
Adjacent areas of untreated skin were used for comparison.
Special notations were made to describe evidence of epidemal and subepidermal destruction. - Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- (24 h exposure)
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 4.3
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks:
- 10 d
- Irritation parameter:
- erythema score
- Basis:
- animal: 8876
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- erythema score
- Basis:
- animal: 8882
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- erythema score
- Basis:
- animal: 8897
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- erythema score
- Basis:
- animal: 8904
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- erythema score
- Basis:
- animal: 8906
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- erythema score
- Basis:
- animal: 8907
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- edema score
- Basis:
- animal: 8876
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- edema score
- Basis:
- animal: 8882
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- edema score
- Basis:
- animal: 8897
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- edema score
- Basis:
- animal: 8904
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- edema score
- Basis:
- animal: 8906
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- edema score
- Basis:
- animal: 8907
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- other: desquamation
- Basis:
- animal: 8882
- Time point:
- 7 d
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure, two treated sites (left and right forelimb)
- Irritation parameter:
- other: desquamation
- Basis:
- animal: 8897
- Time point:
- 7 d
- Reversibility:
- not fully reversible within: 10 day
- Remarks on result:
- other: 4 hour exposure, two treated sites (left and right forelimb)
- Irritation parameter:
- other: desquamation
- Basis:
- animal: 8904
- Time point:
- 7 d
- Reversibility:
- not fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, mean value over two treated sites (left and right forelimb)
- Irritation parameter:
- other: desquamation
- Basis:
- animal: 8906
- Time point:
- 7 d
- Reversibility:
- not fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, two treated sites (left and right forelimb)
- Irritation parameter:
- other: desquamation
- Basis:
- animal: 8907
- Time point:
- 7 d
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, two treated sites (left and right forelimb)
- Irritation parameter:
- other: desquamation
- Basis:
- animal: 8876
- Time point:
- 7 d
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure, two treated sites (left and right forelimb)
- Irritation parameter:
- other: superficial necrosis
- Basis:
- animal: 8897
- Time point:
- 7 d
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, two treated sites (left and right forelimb)
- Irritation parameter:
- other: superficial necrosis
- Basis:
- animal: 8906
- Time point:
- 7 d
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: 4 hour exposure, two treated sites (left and right forelimb)
- Irritant / corrosive response data:
- Irritation was generally mild to moderate (for both 4-h exposure under semi-occlusive and 24-h exposure under occlusive covering). In isolated cases after 4h exposure, scores were graded with 3 to 4 from 24 to 48 h. 1/6 animal exhibited an erythema scored with 4 until day 7, but completely cleared by day 10.
Although 3 of 6 animals had superficial (epidermal) tissue damage at one or more sites, no subepidermal tissue damage was seen.
Desquamation and/or superficial necrosis were not reversible in 5 of 6 animals within 10 or 14 days. - Other effects:
- see above
- Interpretation of results:
- other: CLP/EU GHS criteria met, classified as Skin Irrit. 2 according to Regulation (EC) No 1272/2008
- Conclusions:
- A reliable study, conducted in accordance with FIFRA and TSCA guidelines, found the test material to be irritating to the skin of rabbits. Although the cut-off criteria of ≥ 2.3 for edema and erythema was only reached for one rabbit, desquamation and/or superficial necrosis were noted in all 6 animals and desquamation was not reversible within the observation period (10 to 14 days) in 5 animals.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- Jan 20, 1986 - Feb 13, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Principles of method if other than guideline:
- Study followed principles and procedures of:
- US EPA OPTS, Nov 1982, Section 81-4 (Primary Eye Irritation Study)
-TSCA (US EPA, Aug 1982; Acute exposure, Primary eye irritation) - GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Species: New Zealand White, albino rabbits
- Source: Hazleton-Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel cages
- Diet: Lab Rabbit Chow HF, ad libitum:
- Water: ad libitum
- Acclimation period: 21 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 16°C - 21°C (60 - 70°F)
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye not treated
- Amount / concentration applied:
- 0.1 mL undiluted test material
- Duration of treatment / exposure:
- single dose
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- ADMINISTRATION OF TEST SUBSTANCE
- Introduction of the test material into the lower conjunctival sac of the right eye of each animal
- Control: contralateral (left) eye
REMOVAL OF TEST SUBSTANCE
- Washing: No washing after application
- Time after start of exposure: Approx. 24 h after application , the treated eye was rinsed to remove residual of test material.
SCORING SYSTEM:
- Evaluation of ocular irritation: 1, 24, 48 and 78 h after treatment
- Treated and untreated eyes were scored for ocular reactions according to DRAIZE scale
- Fluorescein dye was used to confirm corneal ulceration in treated eyes starting with the 24 h observation until there was no stain retention for
two observations - Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8864
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8865
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8866
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8869
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8871
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: no. 8866 F and no. 8865 M
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8864
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8865
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8866
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8869
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8870
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8871
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Irritation consisted primarily of mild to moderate conjunctival irritation (redness, chemosis, discharge) and iridial changes (with most severe effects
occurring at one hour after application).
All six animals were free of ocular irritation within 24 to 48 hours after application of the test item. The highest effects score after 24 h was 1 for erythemas in 4/6 animals. - Other effects:
- --
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the acute eye irritation/corrosion test, the test substance did not show irritant properties towards the eyes.
CLP: not classified - Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
--
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Primary irritation to rabbit´s skin (as determined by erythema and edema scores) and was mild to moderate: However, from day 7 of the study epidermal lesions (desquamation and superficial necrosis) were noted in all six animals. Desquamation was not reversible during the observation period (10 -14 days).
Mild eye irritation was only seen 1 h and occasionally 24 h post application. The symptoms observed do not trigger classification. For detailed information see report.
Justification for classification or non-classification
The available data on skin irritatin/corrosion of the test substance meet the criteria for classification as Skin Irrit. 2 according to Regulation (EC) No. 1272/2008 (CLP).
The available data on eye irritatin/corrosion of the target substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Data are therefore conclusive but not sufficient for classification.
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