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Registration Dossier
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EC number: 204-781-0 | CAS number: 126-30-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline 405 (adopted 1981).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2-dimethylpropane-1,3-diol
- EC Number:
- 204-781-0
- EC Name:
- 2,2-dimethylpropane-1,3-diol
- Cas Number:
- 126-30-7
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2,2-dimethylpropane-1,3-diol
- Details on test material:
- 2,2-Dimethyl-1,3-propanediol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa . Dr . Karl Thomae GmbH, Biberach, FRG
- Age at study initiation: no data
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually
- Diet (ad libitum): K4 for rabbits, Ssniff Spezialfutter GmbH, Soest, FRG
- Water (ad libitum): tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 55-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye no treatment
- Amount / concentration applied:
- 0.1 ml or ca. 100 mg test substance (solid) instilled into the conjunctival sac.
- Duration of treatment / exposure:
- no washing
- Observation period (in vivo):
- Scoring 1, 24, 48, and 72 hours and 6, 8, 10, 13, 17, and 21 days after instillation.
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- Scoring system according to OECD Guideline 405; additionally the area of the cornea involved concerning opacity was determined and scored as described in the Table below. The same was done with discharge from conjunctivae (see Table below).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.16
- Max. score:
- 4
- Reversibility:
- not fully reversible within: within 21 days
- Remarks on result:
- other: irreversible damage; in 2 out of 6 rabbits corneal opacity score 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.83
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: score 1 in 2 rabbits at day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: score 1 in 3 rabbits at day 21
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2.16
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritant / corrosive response data:
- The individual results are presented in the Tables below. Critical for evaluation is the opacity of the cornea (grading score 2, area involved score 2) accompanied by circumcorneal injection and iritis at termination (day 21) in 2 out of 6 rabbits (grade 1 for erythema and edema was also found in these 2 animals at termination) and necrosis of nictitating and mucous membrane of the conjunctivae in all rabbits reported the first 72 h.
The authors calculated an irritation index of 31.96 (max. value 110; related to the first 4 time points). - Other effects:
- no
Any other information on results incl. tables
Opacity of the cornea
Scoring according to OECD405 (Op) or according to the Table 'Scoring
of the area of cornea involved' (Ar)
Rabbit |
1 h |
24 h |
48 h |
72 h |
6 d |
8 d |
10 d |
13 d |
17 d |
21 d |
||||||||||
Op |
Ar |
Op |
Ar |
Op |
Ar |
Op |
Ar |
Op |
Ar |
Op |
Ar |
Op |
Ar |
Op |
Ar |
Op |
Ar |
Op |
Ar |
|
M1 |
1 |
4 |
1 |
3 |
2 |
2 |
2 |
3 |
2 |
3 |
1 |
4 |
1 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
M2 |
1 |
2 |
1 |
4 |
1 |
4 |
1 |
3 |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
2 |
2 |
2 |
2 |
M3 |
1 |
1 |
1 |
3 |
1 |
3 |
1 |
2 |
2 |
2 |
2 |
1 |
2 |
1 |
2 |
2 |
2 |
2 |
2 |
2 |
F1 |
1 |
2 |
1 |
4 |
1 |
4 |
2 |
3 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F2 |
1 |
3 |
2 |
3 |
2 |
2 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F3 |
1 |
2 |
1 |
4 |
1 |
3 |
2 |
3 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
M: male; F: female; Op: grade of corneal opacity; Ar: area of cornea involved |
||||||||||||||||||||
x
x
Effects on iris
Scoring according to OECD405
rabbit |
1 h |
24 h |
48 h |
72 h |
6 d |
8 d |
10 d |
13 d |
17 d |
21 d |
||||||||||
Ir |
Ad |
Ir |
Ad |
Ir |
Ad |
Ir |
Ad |
Ir |
Ad |
Ir |
Ad |
Ir |
Ad |
Ir |
Ad |
Ir |
Ad |
Ir |
Ad |
|
M1 |
1 |
R |
1 |
R |
1 |
R |
1 |
R |
1 |
R, In |
1 |
In |
1 |
In |
1 |
In |
0 |
0 |
0 |
0 |
M2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
In |
1 |
In |
1 |
In |
1 |
In |
1 |
In |
1 |
In |
M3 |
0 |
0 |
1 |
R |
0 |
0 |
1 |
R |
0 |
0 |
1 |
In |
1 |
In |
1 |
In |
1 |
In |
1 |
In |
F1 |
0 |
0 |
1 |
R |
0 |
0 |
1 |
R |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F2 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
R |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F3 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
R |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
M: male; F: female; Ir: Scoring of iris according to OECD405; Ad: additional effects described; In: circumcorneal injection; R: iris redened |
||||||||||||||||||||
x
x
x
Erythema (E) and chemosis (C) of the conjunctivae scored according to OECD405
Discharge (D) from conjunctivae (scoring system see Table above in methods)
Rab- bit |
1 h |
24 h |
48 h |
72 h |
6 d |
8 d |
10 d |
13 d |
17 d |
21 d |
||||||||||
E/C |
D/Ad |
E/C |
D/Ad |
E/C |
D/Ad |
E/C |
D/Ad |
E/C |
D/Ad |
E/C |
D/Ad |
E/C |
D/Ad |
E/C |
D/Ad |
E/C |
D/Ad |
E/C |
D/Ad |
|
M1 |
3/1 |
3/- |
3/2 |
2/N |
3/1 |
1/N |
3/1 |
1/N |
3/1 |
1/N |
3/0 |
0/- |
2/0 |
0/- |
1/0 |
0/- |
1/0 |
0/- |
0/0 |
0/- |
M2 |
2/2 |
3/- |
3/3 |
2/N |
3/2 |
2/NA |
3/1 |
1/N |
3/1 |
2/N |
3/1 |
2/N |
3/1 |
1/- |
1/0 |
0/- |
1/0 |
0/- |
1/0 |
0/- |
M3 |
2/2 |
3/- |
3/2 |
2/N |
3/1 |
1/N |
3/1 |
2/N |
2/0 |
2/- |
2/0 |
1/- |
1/0 |
0/- |
2/0 |
0/- |
1/0 |
0/- |
1/0 |
0/- |
F1 |
2/2 |
3/- |
3/2 |
1/N |
3/1 |
0/NA |
3/1 |
1/NA |
1/0 |
0/- |
1/0 |
0/- |
1/0 |
0/- |
1/0 |
0/- |
1/0 |
0/- |
1/0 |
0/- |
F2 |
2/2 |
3/- |
3/2 |
1/N |
3/1 |
2/NA |
3/1 |
1/N |
1/0 |
0/- |
1/0 |
0/- |
0/0 |
0/- |
0/0 |
0/- |
0/0 |
0/- |
0/0 |
0/- |
F3 |
3/2 |
3/- |
3/2 |
1/N |
3/1 |
1/NA |
3/1 |
1/N |
1/0 |
0/- |
1/0 |
0/- |
0/0 |
0/- |
0/0 |
0/- |
0/0 |
0/- |
0/0 |
0/- |
M: male; F: female; Ad: additional effects documented; N: partly necrosis of nictitating and mucous membrane; A: ablation of the mucous membrane |
||||||||||||||||||||
Applicant's summary and conclusion
- Conclusions:
- The instillation of the test substance resulted in serious damage to the eyes.
- Executive summary:
This study is conducted according to OECD Guideline 405 (adopted 1981).
Three Males and 3 females rabbits received instillations of ca. 100 mg crystalline test substance into the left conjunctival sac, the right eye was untreated (control). Scoring according to the Guideline was performed 1, 24, 48, and 72 hours and 6, 8, 10, 13, 17, and 21 days after instillation. The first 72 h after instillation necrosis of nictitating and mucous membrane of the conjunctivae of all 6 rabbits were reported. At termination (day 21) irreversible damage in 2 out of 6 rabbits was obvious: opacity of the cornea (grading score 2, area involved score 2) accompanied by circumcorneal injection and iritis.
Conclusion: The instillation of the test substance resulted in serious damage to the eyes.
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