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EC number: 225-306-3 | CAS number: 4767-03-7
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 May 1999 to 07 December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-bis(hydroxymethyl)propionic acid
- EC Number:
- 225-306-3
- EC Name:
- 2,2-bis(hydroxymethyl)propionic acid
- Cas Number:
- 4767-03-7
- Molecular formula:
- C5H10O4
- IUPAC Name:
- 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material used in the study report: 2,2-Bis(hydroxymethyl)propanoic acid
- Batch no.: SE 8069
- Purity: 99.4 g/100 g (Potentiometric titration)
- Appearance: Solid, white
- Expiry date: not given
- Storage conditions: Room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- The animals were young adult male Himalayan Chbb: HM (outbred strain) rabbits, obtained from Boehringer Ingelheim Pharma KG. The rabbits were acclimatized for at least 1 week. The rabbits weighed 2.42-2.66 kg.
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C temperature and 30 - 70% relative humidity. Light was provided on a 12 hour light/dark cycle. The rabbits were singly housed in stainless steel wire mesh cages with grating, with a floor area of 3000 cm². Bedding was not provided in the cages, wood shavings were placed in the waste trays. Individuals were identified by ear tattoo. The rabbits were provided with approximately 250 mL tap water per animal per day, and approximately 130 gm food per animal per day (Kliba-Labordiaet, Switzerland).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml bulk volume (approximately 33 gm of the comminuted test substance).
- Duration of treatment / exposure:
- The test substance was applied in a single dose to the conjunctival sac of the right eyelid, the substance was washed out with tap water about 24 hours after application (before the 24 h reading).
- Observation period (in vivo):
- 14 days: readings were taken at 1 h, 24 h, 48 h, 72 h, 7 d and 14 d after application.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- The test substance was applied in a single dose to the conjunctival sac of the right eyelid, the substance was washed out with tap water about 24 hours after application (before the 24 h reading). The left eye remained untreated to serve as a negative control.
Checks for dead or moribund animals were made twice each workday and once on weekends and public holidays.
Ocular lesions were assessed according to the scoring system defined in the OECD test guideline 405. The mean values were calculated according to 93/21/EEC (for calculation of the means of corneal opacity, iris, redness and swelling of the conjunctiva only the readings of 24, 48 and 72 hours are used).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- 1 rabbit showed suppuration at the 24, 48 and 72 hour readings. At the 48 and 72 hour readings this rabbit had also developed a contracted pupil and discharge of blood. A second rabbit displayed suppuration, contracted pupil and discharge of blood at the 48 and 72 h readings. These symptoms had disappeared by the 7 day reading. Data are presented in Table 1.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
Table1: Irritant response data
Reading | Rabbit | Cornea | Iris | Conjunctiva | Symptoms | |||
Opacity | Area | Redness | Chemosis | Discharge | ||||
1 h | 1 | 0 | 0 | 0 | 1 | 2 | 3 |
|
2 | 0 | 0 | 0 | 1 | 2 | 2 |
| |
3 | 0 | 0 | 0 | 2 | 2 | 3 |
| |
24 h | 1 | 1 | 1 | 0 | 2 | 2 | 3 |
|
2 | 1 | 1 | 1 | 2 | 3 | 3 |
| |
3 | 1 | 1 | 1 | 3 | 2 | 3 | S | |
48 h | 1 | 0 | 0 | 0 | 2 | 1 | 2 |
|
2 | 1 | 1 | 1 | 3 | 3 | 3 | S, PC, DB | |
3 | 1 | 1 | 1 | 3 | 2 | 3 | S, PC, DB | |
72 h | 1 | 0 | 0 | 0 | 2 | 1 | 2 |
|
2 | 1 | 3 | 1 | 3 | 2 | 3 | S, PC, DB | |
3 | 1 | 3 | 1 | 3 | 2 | 3 | S, PC, DB | |
7 d | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
|
2 | 0 | 0 | 0 | 2 | 1 | 0 |
| |
3 | 0 | 0 | 1 | 2 | 1 | 0 |
| |
14 d | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
|
2 | 0 | 0 | 0 | 0 | 0 | 0 |
| |
3 | 0 | 0 | 0 | 0 | 0 | 0 |
| |
Mean | 1 | 0.33 |
| 0.00 | 2.00 | 1.33 |
|
|
2 | 1.00 |
| 1.00 | 2.67 | 2.67 |
|
| |
3 | 1.00 |
| 1.00 | 3.00 | 2.00 |
|
| |
Mean |
| 0.78 |
| 0.67 | 2.56 | 2.00 |
|
|
Key
S = suppuration
PC = pupil contracted
DB = discharge of blood
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Eye Irritation 2 (H319) according to CLP Regulation 1272/2008 (based on mean irritation, conjunctival redness and chemosis scores >/= 2).
- Conclusions:
- The authors concluded that the results obtained indicate that 2,2-Bis(hydroxymethyl)propanoic acid is irritating to the eye.
- Executive summary:
In a primary eye irritation study (conducted according to OECD TG 405), 0.1 ml of 2,2-Bis(hydroxymethyl)propanoic acid (purity 99.4%) was instilled into the conjunctival sac of 3 young adult Himalayan rabbits (3/males) for 24 hours. The eyes were washed out with tap water 24 hours later. Animals then were observed for 24 h, 48 h, 72 h, 7 d and 14 d after application.The average score (24 to 72 hours) for irritation was calculated to be 0.78 for corneal opacity, 0.67 for iris, 2.56 for conjunctival redness and 2.00 for chemosis. The findings were reversible in all animals within 14 days after application. Symptoms observed included suppuration, contracted pupil and discharge of blood. In this study, 2,2-Bis(hydroxymethyl)propanoic acid is classified as eye irritant 2 (H319) according to CLP Regulation 1272/2008 (based on mean irritation, conjunctival redness and chemosis scores >/= 2).
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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