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Toxicological information

Eye irritation

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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:
other: Comparable to guideline study with acceptable restrictions, Observation was not continued until fully reversibility, or 21 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA 560/6-82-001 (Primary Eye Irritation), August 1982
Deviations:
no
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Guanidine hydrochloride
- crystalline white powder

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, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 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:
other: mean 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:
other: mean 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal: #1, #4, #5, #6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 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:
other: mean 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean 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:
other: mean 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean 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:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: mean 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:
other: mean 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:
other: mean 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:
irritating
Remarks:
Migrated information due to legally binding Classification & Labelling Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008
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.