4-(1,1,3,3-tetramethylbutyl)phenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-05-29 to 1984-06-19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(1,1,3,3-tetramethylbutyl)phenol

EC Number:

205-426-2

EC Name:

4-(1,1,3,3-tetramethylbutyl)phenol

Cas Number:

140-66-9

Molecular formula:

C14H22O

IUPAC Name:

4-(2,4,4-trimethylpentan-2-yl)phenol

Details on test material:

- Name of test material (as cited in study report): Octylphenol PT; Mixture with other isomerioc branched monooctylphenols
- Physical state: solid
- Analytical purity: 96% (provided by sponsor, not part of the study report)
- Impurities (identity and concentrations): not mentioned
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: not mentioned
- Production date of the lot/batch: not mentioned
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned

Test animals / tissue source

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 1.85 - 2.68 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 and 72 hours, and 6, 7, 9, 14, 16 and 21 days after application

Number of animals or in vitro replicates:

3 male + 3 female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after application, the treated eyes were checked for cornea damage with sodium fluoresceine solution and then rinsed with warm physiological saline

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 hours after administration

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

38.4

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

AVERAGE SCORE according 79/831/EEC Annex VI
- Cornea: 1.44
- Iris: 1.00
- Conjuntivae (Redness): 3.00
- Conjuntivae (Chemosis): 1.44

Other effects:

24 hours after treatment all animals showed redness and evident chemosis of conjunctiva. Increased chemosis was seen at the following examinations: exudation, necrosis and white settlings in the conjuctival sac. The iris was reddish discoloured. All animals showed cornea pannus and extreme circumcorneal injection after 6 days.

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4  male: 1 / 2 / 3 female : 4 / 5 / 6	Max. score: 2  male: 1 / 2 / 3 female : 4 / 5 / 6	Max. score: 3  male: 1 / 2 / 3 female : 4 / 5 / 6	Max. score: 4  male: 1 / 2 / 3 female : 4 / 5 / 6
60 min	0 / 0 / 0 / 0 / 0 / 0	0 / 0 / 0 / 0 / 0 / 0	1 / 2 / 1 / 2 / 2 / 2	1 / 2 / 2 / 1 / 2 / 1
24 h	1 / 1 / 1 / 1 / 1 / 2	1 / 1 / 1 / 1 / 1 / 1	2 / 2 / 3 / 3 / 3 / 3	2 / 2 / 3 / 3 / 3 / 3
48 h	1 / 1 / 1 / 1 / 1 / 2	1 / 1 / 1 / 1 / 1 / 1	2 / 2 / 3 / 2 / 3 / 3	2 / 2 / 3 / 3 / 3 / 3
72 h	2 / 2 / 2 / 2 / 2 / 2	1 / 1 / 1 / 1 / 1 / 1	1 / 2 / 2 / 3 / 3 / 3	1 / 1 / 2 / 1 / 1 / 1
Average 24h, 48h, 72h	1.44	1.00	2.50	2.17
Area effected
Maximum average score (including area affected, max 110)
Reversibility*)	n.	n.	n.	c.
Average time (unit) for reversion	-	-	-	21

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

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:

Octylphenol PT is moderate irritating to the eye with a primary irritation index of 38.42/110. Severe ocular lesions occur after 72h. Due to the delayed effect and the persistency of the lesions the substance is classified Category 1 “irreversible effects on the eye”.

Executive summary:

In a primary eye irritation study, 0.1 g of p-(1,1,3,3-Tetramethylbutyl)-phenol was instilled into the conjunctival sac of the right eye of Small White Russia rabbits (3/sex) for 24 hours.  After application, the treated eyes were checked for cornea damage and rinsed with warm physiological saline. Animals then were observed for 21 days.  Irritation was scored by the method of Draize (1959).

24 hours after treatment all animals showed redness and evident chemosis of conjunctiva. Increased chemosis was seen at the following examinations: exsudation, necrosis and white settlings in the conjuctival sac. The iris was reddish discoloured. All animals showed cornea pannus and extreme circumcorneal injection after 6 days.

In this study, p-(1,1,3,3-Tetramethylbutyl)- is moderately irritating to the eye based on an irritation index of 38.42/110. Severe ocular lesions occur after 72h. Due to this delayed effect and the persistency of these lesions the substance is classified Category 1 "irreversible effects on the eye” according CLP-Regulation (EC) No 1272/2008.