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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is very old. Observation is poor. Number of animals is only two. But result is clear, and allows a final evaluation.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
No information on guideline available.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HN-2200
- Lot/batch No.: 103
- Molecular formula (if other than submission substance): C9 H10 O3
- Molecular weight (if other than submission substance): 166.18
- Smiles notation (if other than submission substance): O=C(OC(=O)C1CC=C(C2)C)C12
- InChl (if other than submission substance): 1/C9H10O3/c1-5-2-3-6-7(4-5)9(11)12-8(6)10/h2,6-7H,3-4H2,1H3
- Structural formula attached as image file (if other than submission substance): see Fig. (11070-44-3 structure.png)

Test animals / tissue source

Species:
rabbit
Strain:
Belgian Hare
Details on test animals or tissues and environmental conditions:
no details given

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one eye for test other eye for vehicle control for each animal.
Amount / concentration applied:
0.1ml of the liquid was applied (undiluted and 10 times diluted with olive oil) to one eye for each animal.
The other eye was treated with 0.1 ml olive oil and served as reference.
Duration of treatment / exposure:
no details given
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
Two rabbits (undiluted and ten times diluted solution)
Details on study design:
not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 min
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: Score is in accordance with OECD guideline 405.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 min
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: Score is in accordance with OECD guideline 405.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 H
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: Score is in accordance with OECD guideline 405.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 H
Score:
0
Max. score:
3
Remarks on result:
other: Score is in accordance with OECD guideline 405.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 H
Score:
0
Max. score:
4
Remarks on result:
other: Score is in accordance with OECD guideline 405.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 10 days
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: Score is in accordance with OECD guideline 405.
Irritant / corrosive response data:
In case of 0.1ml of MTHPA, eye was closed immediately. Haze was observed after 1 minute. After 24 hours, bloodshot were observed. Blindness
or bleeding were not observed. After 10 days, the eye was able to be half-opened. Then reaction of light was recovered in normal condition.
In case of 0.1ml MTHPA diluted 1:10 in olive oil, eye was closed after 1 minutes. After 24 hours, eye was only half-opened and bloodshot were also observed. After 7-10 days, it recovered in normal condition.
Other effects:
no details given

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tetrahydromethylphthalic anhydride (MTHPA) is seriously eye damaging applied to the rabbits eye.
Executive summary:

In a primary eye irritation study, 0.1 ml of methyl tetrahydrophthalic anhydride (MTHPA) was instilled into the conjunctival sac of Belgian Hare. Animals then were observed for 10 days. In case of 0.1 mL of MTHPA, eye was closed immediately. Haze was observed after 1 minute. After 24 hours, iris injection and circumcorneal injection were observed. Blindness or bleeding were not observed. After 10 days, the eye was able to be half-opened. Eyes recovered to normal condition within 14 days. In case of 0.1 mL MTHPA diluted 1:10 in olive oil, eye was closed after 1 minutes. After 24 hours, the eye was only half-opened and bloodshot. After 7-10 days, it recovered in normal condition. In conclusion, MTHPA was classified seriously eye damaging.