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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is sufficiently described and the method is similar to EU and OECD test guidelines. Study performed before GLP establishment.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: 92/69/EEC, B.5
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
Study performed before GLP establishment

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexamethylenediamine
EC Number:
204-679-6
EC Name:
Hexamethylenediamine
Cas Number:
124-09-4
Molecular formula:
C6H16N2
IUPAC Name:
hexane-1,6-diamine
Details on test material:
- Name of test material (as cited in study report): 7273 R.P. , Hexamethylene Diamine
- Substance type: technical product
- Physical state: liquid
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.0 to 2.6 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1g
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
No

SCORING SYSTEM: according to Draize


TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
ca. 3.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
See table 7.3.2/1
Other effects:
No data

Any other information on results incl. tables

Table 7.3.2/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point

Cornea

Max. score: 4

Iris

Max. score: 2

Conjuntivae

Max. score: 3

Chemosis

Max. score: 4

60 min

4/4/4/4

2/2/2/2

3/3/3/3

3/3/3/3

24 h

4/4/4/4

2/2/2/2

3/3/3/3

3/3/3/3

48 h

4/4/4/4

2/2/2/2

3/3/3/3

4/4/4/4

72 h

4/4/4/4

2/2/2/2

3/3/3/3

4/4/4/4

Average 24h, 48h, 72h

4

2

3

3,7

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, HMD is considered in Category 1 (irreversible effects on the eye) according to the CLP regulation (1272/2008) and as eye damaging (Xn, R41) according to the Directive 67/548/EEC.
Executive summary:

In an eye irritation/corrosion study (Marzin, 1978) similar to 92/69/EEC, B.5 guideline, 4 New Zealand White rabbits were treated with Hexamethylene diamine (HMD). 0.1g of HMD was applied onto rabbit eyes.

Scores were recorded for cornea, iris, conjunctivae and chemosis were recorede at 1, 24, 48 and 72 hours. The overall irritation score for all animals at 24, 48 and 72 hours was 3. All these effects were not reversible at 72 hours after application. Under the test conditions, Hexamethylene diamine is considered as highly irritating.

Based on these results, HMD is considered in Category 1 (irreversible effects on the eye) according to the CLP regulation (1272/2008) and as eye damaging (Xn, R41) according to the Directive 67/548/EEC. However this classification should be waiving since HMD is classified as corrosive (C, R34) and in category 1B in the Annex VI (Table 3.1 & 3.2) of the CLP regulation (1272/2008).