Registration Dossier
Registration Dossier
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EC number: 200-002-3 | CAS number: 50-01-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-05-03 to 1984-06-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 560/6-82-001 (Primary Eye Irritation), August 1982
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation was not continued until fully reversibility, or 21 days.
- GLP compliance:
- yes
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elkhorn Rabbitry, 5265 Starr Way, Watsonville, CA 95076
- Age at study initiation: young adults
- Weight at study initiation: 2.3 - 2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): 150 g of Certified Purina Chow Diet 5322
- Water (e.g. ad libitum): d libitum
- Acclimation period: 14 d minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.1 to 20.0°C, except for a spike to 21.1°C during a steam outage
- Humidity (%): 40 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL was recalculated to mg: 81.4 mg ± 1.0 mg - Duration of treatment / exposure:
- no removal of the test substance
- Observation period (in vivo):
- 14 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein for scoring at 24 h, 7 and 14 d
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- - slight corneal opacity (grade 1) was observed in 3/6 rabbits for up to 4 days
- 2/6 animals showed slight iritis (vascular injection; grade 1) after 24 h, this was reversible after 48 h and 4 d, respectively
- slight to moderate conjunctival redness (grade 1 - 2) was observed in all animals, reversibility was achieved in 5/6 animals within 14 d
- in one animal slight redness (grade 1) was still present on day 14, but this can be judged as resolution of the initial lesion and can therefore expected to be reversible within 21 d
- slight to moderate chemosis (grade 1 - 2) was observed in all animals being fully reversible within 14 d
Any other information on results incl. tables
| Animal number | Cornea score1 h/ 1/2/3/4/7/14 d | Iris score 1 h/ 1/2/3/4/7/14 d | Conjunctival redness score 1 h/ 1/2/3/4/7/14 d | Conjuntival chemosis score 1 h/ 1/2/3/4/7/14 d |
| 1 | 0/0/0/0/0/0/0 | 0/0/0/0/0/0/0 | 1/1/2/1/1/1/0 | 1/0/0/0/0/0/0 |
| 2 | 1/1/1/1/1/0/0 | 0/1/1/1/1/0/0 | 1/2/2/2/2/1/0 | 2/1/1/1/2/1/0 |
| 3 | 0/0/1/1/1/0/0 | 0/1/0/0/0/0/0 | 0/1/1/1/0/1/0 | 1/2/1/0/1/0/0 |
| 4 | 0/0/1/0/0/0/0 | 0/0/0/0/0/0/0 | 1/1/2/2/2/1/0 | 2/2/2/1/1/1/0 |
| 5 | 0/0/0/0/0/0/0 | 0/0/0/0/0/0/0 | 1/1/1/1/1/0/0 | 1/1/1/0/0/0/0 |
| 6 | 0/0/0/0/0/0/0 | 0/0/0/0/0/0/0 | 1/1/2/2/2/1/1 | 2/1/2/1/1/1/0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Guanidine hydrochloride is legally classified as irritating to the eye (CLP, EU GHS (Regulation (EC) No 1272/2008)).
- Executive summary:
In a primary eye irritation study similar to OECD guideline 405, 81.4 ± 1.0 mg (corresponding to 0.1 mL) of Guanidine hydrochloride (98% purity) was instilled into the conjunctival sac of 6 male, young adult New Zealand White rabbits. The eyes were not rinsed. Animals then were observed for 14 days. Irritation was scored similar to OECD guideline 405, at 1, 4, 24, 48 and 72 hours and at 7, 14 and 21 days. At 24, 48, 72 hours as well as 7 and 14 days post application the eyes were further examined with fluorescein to look for cornea damage.
Slight corneal opacity (grade 1) was observed in 3/6 rabbits for up to 4 days. 2/6 animals showed slight iritis (vascular injection; grade 1) after 24 h, which was reversible within 4 d. Slight to moderate conjunctival redness (grade 1 - 2) was observed in all animals; reversibility was achieved in 5/6 animals within 14 d. In one animal slight redness (grade 1) was still present on day 14, but this was judged as resolution of the initial lesion by the study authors and can therefore be expected to be fully reversible within 21 d, although observation was not continued until full reversibility was achieved. Slight to moderate chemosis (grade 1 - 2) was observed in all animals being fully reversible within 14 d.
Guanidine hydrochloride is legally classified as irritating to the eye.
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