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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:
weight of evidence
Study period:
1987-09-01 until 1987-09-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study. Read-across justification: The substance is hydrolytically unstable. When it comes in contact with water or moisture complete hydrolysis will take place with no significant reaction products other than alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the toxicokinetics of target substance. Because of the rapid hydrolysis, the influence of the mode of administration through inhalation, dermal and oral is related to the hazardous degradation product (alcohol) released from the target substance. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance, which might change the hazardous properties of the target substance compared to the properties of the pure alcohol. As there is a mechanistic reasoning to the read-across, the unnecessary animal testing is avoided by using the read-across data from the degradation product (relevant alcohol) to evaluate irritation, sensitization and the short term and long-term toxicological effects and mutagenicity of the target substance.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4
- Analytical purity: 99.5%

Test animals / tissue source

Species:
rabbit
Strain:
other: Small Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: singly in stainless steel cages
- Diet: diet K4, Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 hrs


IN-LIFE DATES: From: day 0 (initiation) To: day 21 after treatment

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: according to Draize (OECD 405)


TOOL USED TO ASSESS SCORE: fluorescein


EVALUATION:
1) Modified Maximum Average Score (MMAS) according to Draize (1944; cf. ECETOC (1998), company study T01716)
2) Average scores according to EU (79/831/EEC)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: MMAS
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, and 72 hrs
Score:
28.59
Reversibility:
fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hrs
Score:
1.44
Max. score:
2
Reversibility:
fully reversible within: 17 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hrs
Score:
0.89
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hrs
Score:
2.56
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 hrs
Score:
0.78
Max. score:
3
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Read-across justifications and data matrices are presented in IUCLID section 13.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
2-EH was markedly irritant to the rabbit's eye in a valid OECD 405 test. The effects were fully reversible within 21 days. The mean conjunctivae score (reddening) was 2.56 and exceeded slightly the EU criterion for classification (R36).
Executive summary:

2-EH was markedly irritant to the rabbit's eye in a valid OECD 405 test using 3 animals. Moderate corneal opacity was seen in all animals at 24 and 48 hours after treatment. The effect was absent in 2 animals at 72 hours after treatment and at 17 days in the third animal. Grade 1 iritis was noted in all animals. The effect was absent in two animals on day 6, and on day 21 in the third animal. Moderate reddening of the conjunctivae was seen in all animals at 24 and 48 hours after treatment. Two animals were free of this effect on day 8, the third on day 21. Chemosis was slight in two animals, and on day 8 all animals were free of this effect.

To conclude, 2-EH caused moderate eye irritation in all 3 treated animals. The effects were fully reversible within 21 days. The MMAS (Mean Modified Average Score) according to Draize was 28.59. The mean conjunctivae score (reddening) was 2.56 and exceeded slightly the EU criterion for classification (R36) (Hüls AG, 1987).