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EC number: 938-875-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The available irritation studies demonstrated only limited irritation to the skin, eye and respiratory system.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Oct. 2, 1990- Oct. 23, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week
IN-LIFE DATES: From: Oct. 2, 1990 To: Oct. 23, 1990 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control area on each test animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml undiluted - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 21 days
- Number of animals:
- 6 - 3 males, 3 females
- Details on study design:
- TEST SITE
- Area of exposure: An 8 x 8 cm dorsal area of the trunk was clipped. Part of this area was used as a control.
- % coverage: An approximately 2.5 x 2.5 cm area of the trunk was covered.
- Type of wrap if used: Test material was placed beneath two single layers of surgical gauze which were secured with non-irritating adhesive tape. Trunks of the animals were wrapped with semi-permeable dressing held in place with non-irritating adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with room temperature tap water and wiped with a wet cloth.
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hrs
- Score:
- 1.22
- Max. score:
- 2
- Reversibility:
- other: 21 days
- Remarks on result:
- other: Fully reversible in all but 2 animals (very minor redness observed)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- All animals showed very slight erythema/eschar at the 3-4 hrs observation. This persisted in all animals until at least day 10, with some animals showing an increase to a score of 2. The erythema/eschar did not resolve in two of the animals by the end of the experiment at day 21. Two animals showed very slight edema at the .75 hr observation, with all animals showing this at the 24 hr observation. The edema symptoms did not worsen, and resolved in all animals by day 21.
- Other effects:
- No other effects were seen in any animal at any observation.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
This study examined the skin irritancy of MR Solvent to rabbit skin. 3 male and 3 female rabbits were exposed dermally to 0.5 ml of test substance for 4 hrs. Test substance was applied to a clipped dorsal area and the area occluded. After 4 hrs, the test areas were washed with tap water. Once the test substance was removed, the animals were scored for skin irritation. Additional observations were made at 24, 48, and 72 hrs, and 7, 10, 14, 17, and 21 days after removal. Animals exhibited very slight erythema and edema (score of 1) beginning at the first observation. By the 24 hr observation, some of the erythema scores had risen to 2, which reversed by day 10. All edema symptoms had resolved by day 21, however, two animals still had very slight redness on day 21. No other signs of skin irritation were seen. The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Reference
Animal |
Observation |
|||||||||
Hours |
Days |
|||||||||
3-4 |
24 |
48 |
72 |
7 |
10 |
14 |
17 |
21 |
||
9918-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9920-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9922-M |
Erythema/eschar |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9913-F |
Erythema/eschar |
1 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9915-F |
Erythema/eschar |
1 |
1 |
1 |
1 |
2 |
2 |
1 |
1 |
0 |
Edema |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
|
9917-F |
Erythema/eschar |
1 |
1 |
1 |
2 |
2 |
2 |
1 |
1 |
1 |
Edema |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
|
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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Oct. 1, 1990 - Oct. 4, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week
IN-LIFE DATES: From: Oct. 1, 1990 To: Oct. 4, 1990 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the non-treated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water 30 seconds after start of exposure. The eyes of the remaining 6 animals were unwashed.
- Observation period (in vivo):
- 72 hrs at which time no animals showed signs of irritation.
- Number of animals or in vitro replicates:
- 9 animals total
3 males and 3 females were used in the unwashed eye experiment
3 males were used in the washed eye experiment - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water. The eyes of the remaining 6 animals were unwashed.
- Time after start of exposure: 30 seconds after start of exposure
SCORING SYSTEM: According to EPA guidelines 81-4
TOOL USED TO ASSESS SCORE: All animals were examined with 0.2% fluorescein sodium ophthalmic solution at the 24 hr observation . Since no fluorescein staining was seen in any animal, the examination was not repeated at later observations. - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritant / corrosive response data:
- All six of the unwashed animals showed redness (score of 1) at the 1 and 24 hr observations. The three females and one male also showed chemosis (score of 1) at the 1 hr observation. All symptoms were resolved at the 48 hr observation. All three washed animals showed redness (score of 1) at the 1 and 24 hr observation. These symptoms were also resolved by the 48 hr observation.
- Other effects:
- No other effects were observed in any animal at any observation.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
- Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Reference
Individual Eye Irritation Scores - Washed
Animal |
1 hr |
24 hrs |
48 hrs |
72 hrs |
|
9960-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9962-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9964-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
Individual Eye Irritation Scores - Unwashed
Animal |
1 hr |
24 hrs |
48 hrs |
72 hrs |
|
9954-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9956-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9958-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9957-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9959-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9961-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The irritation assessment of Alchisor TAL 111 is based on read-across data from C9-C14 aliphatics (2-25% aromatics) and Alchisor TAL 123.
A skin irritation study on C9-C14 aliphatics (2-25% aromatics) gave rise to some irritation but insufficient to meet the classification criteria. An eye irritation study on C9-C14 aliphatics (2-25% aromatics) also gave rise to some irritation but insufficient to meet the classification criteria.
Respiratory Irritation
Human Exposure - There are no reports of respiratory irritation in humans associated with exposure to C9-C14 aliphatic solvents. Two studies have been reported in which volunteers were exposed to C9-C14 aliphatic solvents at differing concentrations. In the first of these, 6 volunteers were exposed for 15 minutes at levels ranging from 24-470 ppm (126-2468 mg/m3) and, after exposure, asked to report their symptoms. There were no reports of throat irritation at the two lower concentrations and only one of the 6 reported throat irritation at the highest level (Carpenter et al., 1975). In the second study (Lammers et al., 2007), there was no evidence of respiratory irritation in volunteers at levels of 570 mg/m3. Animal Exposure - In the first of these studies (Carpenter et al., 1975a), a 50% depression in respiratory rate was observed in mice exposed to 10,000 mg/m3 (1700 ppm), but not at 4.4 mg/l (770 ppm). In the second of these studies (ExxonMobil Biomedical Sciences, Inc., 1988), a maximum exposure concentration of 170 ppm (935 mg/m3) produced a respiratory depression of 15%, a response which was considered to be slightly irritating. Taken as a whole, the animal data suggest that C9-C14 aliphatic solvents are not highly irritating to the respiratory tract and certainly not at occupational levels. The results of the volunteer studies demonstrate that C9-C14 aliphatic solvents are not respiratory irritants to humans.
Justification for selection of skin irritation / corrosion endpoint:
Two skin irritation studies are available. The selected study has the higher Klimisch score.
Justification for selection of eye irritation endpoint:
Two eye irritation studies are available. The selected study has the higher Klimisch score.
Justification for classification or non-classification
Based on the available read-across data, the substance does not meet the criteria for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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